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  • Member Page | MC Pharma New v5

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  • Adverse Drug Reactions | MC Pharma

    Comprehensive Management of... Adverse Drug Reactions Prioritizing Patient Safety and Regulatory Compliance Adverse Drug Reactions (ADRs) are a critical concern in the pharmaceutical industry. MC Pharma places paramount importance on understanding, managing, and reporting ADRs to ensure patient safety and adhere to regulatory standards for products registered on our license. Stay Informed, Stay Safe Contact us to report products registered under our license Reach out to MC Pharma for expert guidance on Adverse Drug Reaction management. Our dedicated team is ready to assist you in navigating the complexities of ADR reporting and management, ensuring a safer pharmaceutical practice. Adverse Drug Reaction Form What Are Adverse Drug Reactions? The Implications of ADRs in Pharmaceutical Operations An adverse drug reaction is an unwanted or harmful reaction experienced following the administration of a medicine. Understanding the types, causes, and implications of ADRs is crucial for ensuring patient safety and regulatory compliance. Learn More Adverse Drug Reaction Assistance Form Adverse Drug Reaction Assistance Form for products registered on MC Pharma’s license First name* Last name* Email* Phone Product Name* Are you currently experiencing a reaction?* Yes No Please explain in as much detail as possible what reaction you are experiencing and what you think caused it.* Submit Reach Out For Assistance FAQ's What are adverse drug reactions? ADRs are unwanted, uncomfortable, or dangerous effects that drugs may have . They can be considered a form of toxicity . ADRs can occur due to overingestion (accidental or intentional) or to elevated blood levels or enhanced drug effects that occur during appropriate use . How do companies monitor adverse drug reactions? Companies monitor ADRs through various methods including formal drug safety studies, published data, pharmaceutical company data from periodic safety update reports (PSURs), and shared international data . They also use specific investigations and laboratory tests . What is the process to report an adverse drug reaction? The process to report an ADR involves healthcare professionals or patients reporting suspected adverse reactions to regulatory bodies . This can be done via specific software, email, fax, or post . How do adverse drug reactions impact drug approvals? ADRs can impact drug approvals as negative results are less likely to be published than positive results . Regulatory bodies may require additional information to establish the safety, quality, and efficacy of medicines . What are the most common adverse drug reactions reported? Common ADRs include upset stomach, dry mouth, and drowsiness . Digestive disturbances such as loss of appetite, nausea, bloating sensation, constipation, and diarrhea are also common . How can patients avoid adverse drug reactions? Patients can avoid ADRs by keeping a list of their medicines, following directions, asking questions, keeping up with any blood testing recommended by their doctor, and taking all medicines only as directed . What role do healthcare professionals play in monitoring adverse drug reactions? Healthcare professionals play a key role in monitoring ADRs. They are best placed to report suspected adverse reactions as part of patient care . How do regulations ensure the reporting of adverse drug reactions? Regulations ensure the reporting of ADRs by requiring manufacturers of prescription medical products to submit adverse event reports to regulatory bodies . Regulatory bodies may also request any additional information to establish the safety, quality, and efficacy of medicines . What are the challenges in monitoring adverse drug reactions? Challenges in monitoring ADRs include the increasing complexity of therapeutics, an ageing population, rising multimorbidity , and issues with pharmacovigilance systems such as lengthy and complicated reporting forms . How do companies ensure the safety of their drugs post-adverse reactions? Companies ensure the safety of their drugs post-ADRs through periodic, unannounced inspections of drug production and control facilities . If a drug has the potential for serious adverse effects, regulatory bodies may require that the manufacturer establish a Risk Evaluation Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh the risks .

  • Strategic Pharmaceutical Service Partnerships | MC Pharma

    Pharmaceutical Service Partnerships A Network of Expertise Cultivating Synergies with Industry Leaders This collaborative approach amplifies our service capabilities, offering a holistic spectrum of pharmaceutical solutions to our clients Our partnerships with seasoned pharmaceutical service providers enhance our service offerings, ensuring a rich blend of expertise and resources dedicated to fulfilling the diverse needs of our clientele. Broadening Horizons Through Collaborative Partnerships Pharmaceutical Service Partners Partnerships Mnandi Pharma Medical Device Market Entry Mnandi Pharma provides professional regulatory assistance to companies wishing to enter the South African medical device market through our Applicant Solutions, reducing the risk of obtaining and maintaining a license in accordance with the laws and regulations. Learn More Our Global Footprint Our Partners and Clients Beyond our local partnerships and clients, MC Pharma is also connected with a network of global partners, expanding our reach and capability in delivering comprehensive pharmaceutical solutions across borders. Become Global Join Our Network of Pharmaceutical Pioneers Explore Partnership Opportunities with MC Pharma Engage with MC Pharma to discover a world of partnership opportunities. Together, we can create a robust pharmaceutical service ecosystem, fostering innovative solutions and mutual growth. Form Partnership

  • Pharmaceutical Regulatory Services in South Africa | MC Pharma

    Your Trusted Partner in Africa Market Entry to Market Leadership Navigating Regulatory Paths, Building Market Leadership A seamless journey, with MC Pharma, your partner in sales, marketing and tenders in Africa Book Consultation Our affiliations from reputable bodies affirm our competence and commitment to adhering to the highest standards of regulatory compliance. Our Affiliations MC Pharma is a specialist pharmaceutical company, adept in navigating the complex regulatory environment, ensuring that products meet the stringent compliance requisites of African markets. Who We Are Expertise Rooted in Experience Learn More From Registration Strategies to Marketing & Sales, our modular services are meticulously crafted to align with your market entry and growth aspirations. Tailored for Your Success Our Service Spectrum All Services ​Regulatory Intelligence Regulatory Consulting and Quality Assurance Sales and Marketing We have a passionate and innovative Sales & Marketing Team that delivers a spectrum of services Section 21 ​Authorisation Granted by SAHRPA Import & Export Services Distribution and Wholesale New Business Development ​Business Development Services Our Products Suite Compliant, Reliable, and Market-Ready Explore our range of products, each engineered to meet the rigorous regulatory standards of the pharmaceutical landscape in South Africa. Our Products Medical Products Explore our range Medical products already approved for South African market. Our Products Industry Insights Stay Updated, Stay Ahead Dive into the latest updates and trends in the pharmaceutical industry to keep your operations compliant and competitive. All Articles Adverse Drug Reaction Reporting Ensuring Patient Safety Report adverse drug reactions promptly, aiding in the continuous effort to uphold patient safety and product efficacy. Approach ADR's Correctly Connect With Us Your Success, Our Priority Reach out to our team of seasoned professionals to discuss how MC Pharma can facilitate your pharmaceutical market entry and compliance journey in Africa. Contact Us Our Partners Collaborative Growth Meet our global partners who have leveraged MC Pharma’s expertise for successful market entry and regulatory compliance in Africa. Partners Our Global Footprint International Collaborations Beyond our local partnerships, MC Pharma is also connected with a network of global partners, expanding our reach and capability in delivering comprehensive pharmaceutical solutions across borders. Become Global

  • Meet The Management Team | MC Pharma

    A Legacy of Regulatory Excellence Meet the Management Team Connect with Expertise MC Pharma embodies a legacy of trust, proficiency, and collaborative growth, extending a suite of comprehensive services to navigate the complex pharmaceutical terrain. The Executive Team Committed to Excellence Our values of integrity, innovation, and partnership remain the compass that guides our actions, fostering a culture of trust, adaptability, and collaborative growth. Tracy Burger Executive Chairman of the Board Junita Castle Executive Finance and Logistics Jaco Van Der Wath Executive Sales and Marketing Declan Burger Executive Compliance Management Structure

  • Elevating Compliance with Regulatory Pharmaceutical Services | MC Pharma

    Pharmaceutical Regulatory Intelligence Regulatory Excellence, Quality Assured Your Bridge to Compliance and Market Success MC Pharma's Regulatory Affairs and Quality Assurance services serve as a catalyst, ensuring your pharmaceutical journey is compliant, quality-driven, and market-ready. 1 Compiling and submission of ZA-eCTD applications for Medicines, Medical Devices and Health Products 2 eCTD compilation, submission and full CTD life-cycle management including updates and amendments. 3 Package insert and patient information leaflet development. 4 Registration gap-analysis data reporting. 5 Site Master File (“SMF”) in accordance with the Preparation of a Site Master File Guideline (4.08). 6 Import/Export and Distribution logistics of regulated pharmaceuticals 7 Development of Quality Management System (“QMS”) in compliance with GLP 8 Quality Manual 9 Standard Operating Procedures 10 Application for South African National Accreditation System (SANAS) GLP Certification Regulatory and Quality Assurance Your Quality Assurance Advocate Upholding Quality, Ensuring Compliance MC Pharma's Quality Assurance services epitomize a commitment to superior quality, ensuring your products meet the stringent regulatory standards while upholding the trust and confidence of your stakeholders. Contact Us Equip Yourself with Regulatory Knowledge Resources for Informed Decision-Making Access a reservoir of educational resources on Regulatory Affairs and Quality Assurance, arming you with the knowledge for informed decision-making in your pharmaceutical journey. Industry News Regulatory and Quality Experts Initiate Your Compliance Journey Elevate your compliance standards by engaging with MC Pharma's Regulatory and Quality Assurance experts. Contact us to initiate your journey towards market success with uncompromised quality. Book Consultation Regulatory Affairs Consulting and Management Send Tailored Quality Assurance Strategies Send Your Bridge to Compliance and Market Success Send Navigation of Regulatory Pathways Send Explore MC Pharma's multifaceted approach to Regulatory Affairs and Quality Assurance, tailored to meet the rigorous standards of the pharmaceutical industry while aligning with your strategic objectives. Quality Assurance Tailored to Your Needs Comprehensive Regulatory Pharmaceutical Services All Services FAQ's Your Queries Addressed What are regulatory pharmaceutical services? As a specialist pharmaceutical company that offers regulatory pharmaceutical services to help pharmaceutical companies comply with regulatory requirements and guidelines. These services include regulatory consulting, regulatory writing, regulatory submissions, and regulatory compliance1 . Why are regulatory pharmaceutical services crucial for drug manufacturers? Regulatory pharmaceutical services are crucial for drug manufacturers because they help ensure that the drugs they produce are safe, effective, and meet regulatory requirements. MC Pharma’s regulatory pharmaceutical services help drug manufacturers navigate the complex regulatory landscape and ensure that their products are approved for sale in the market . How do regulatory pharmaceutical services aid in drug approvals? MC Pharma’s regulatory pharmaceutical services aid in drug approvals by providing support throughout the drug development process. These services help drug manufacturers prepare and submit regulatory documents, such as Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Biologics License Applications (BLAs). They also help manufacturers comply with regulatory requirements and guidelines throughout the drug development process . What is the scope of regulatory pharmaceutical services? The scope of MC Pharma’s regulatory pharmaceutical services includes regulatory consulting, regulatory writing, regulatory submissions, and regulatory compliance. These services help drug manufacturers comply with regulatory requirements and guidelines throughout the drug development process . Which companies offer the best regulatory pharmaceutical services in South Africa? As the industry leader in regulatory pharmaceutical services in South Africa. Their services are highly sought after by pharmaceutical companies in the region. MC Pharma’s regulatory pharmaceutical services are known for their quality, reliability, and effectiveness . How do regulatory pharmaceutical services ensure compliance with SAHPRA? MC Pharma’s regulatory pharmaceutical services ensure compliance with SAHPRA by helping drug manufacturers navigate the complex regulatory landscape and ensuring that their products meet regulatory requirements. These services help manufacturers prepare and submit regulatory documents, such as IND applications, NDAs, and BLAs, and comply with regulatory requirements and guidelines throughout the drug development process . What are the costs associated with regulatory pharmaceutical services? The costs associated with MC Pharma’s regulatory pharmaceutical services vary depending on the type of service required and the complexity of the project. MC Pharma offers competitive pricing for their services and ensures that their clients receive value for their money . How do regulatory pharmaceutical services differ from clinical trial services? Regulatory pharmaceutical services differ from clinical trial services in that they focus on regulatory compliance and drug approvals, while clinical trial services focus on conducting clinical trials. MC Pharma’s regulatory pharmaceutical services help drug manufacturers comply with regulatory requirements and guidelines throughout the drug development process, while clinical trial services help manufacturers conduct clinical trials to test the safety and efficacy of their products . Can international companies avail regulatory pharmaceutical services in South Africa? Yes, international companies can avail MC Pharma’s regulatory pharmaceutical services in South Africa. MC Pharma has a wealth of global clients in countries such as the UK, Australia, France, Germany, Brazil, China, India, and the USA . What are the challenges faced by regulatory pharmaceutical services? Some of the challenges faced by regulatory pharmaceutical services include navigating the complex regulatory landscape, keeping up with changing regulations and guidelines, and ensuring that products meet regulatory requirements. MC Pharma’s regulatory pharmaceutical services have a proven track record of overcoming these challenges and ensuring that their clients’ products are safe, effective, and meet regulatory requirements . 1 We purchase the stock 2 We import the stock 3 We pay the yearly retention fees to SAHPRA 4 We will share all the post importation testing and transport validation reports with the principle 5 Adverse reactions (PV) report will be sent to DRCONSULTING and the principle 6 We are liable to keep the dossier updated as to SAHPRA requirements If MC Pharma Has Sole Distribution Rights

  • Your Pharmaceutical Regulatory Partner | MC Pharma

    Reach Out To... Your Trusted Pharmaceutical Regulatory Partner Bridging Your Path to Market Compliance At MC Pharma, we value open communication and are keen on assisting you through your pharmaceutical regulatory journey in Africa. Contact us to discuss your needs and discover how our expertise can serve you. Ready to Explore Unmatched Regulatory Expertise? Your Regulatory Success, Our Priority Your inquiries are important to us. Fill out the form below or call us to discuss your pharmaceutical regulatory requirements. Our team is ready to provide the guidance and services you need. Contact Us Find us at our office address for a face-to-face consultation by appointment only. Our doors are open from Monday to Friday during regular business hours. We are looking forward to discussing your pharmaceutical regulatory projects. Book Your Personal Consultation With Us Our Office Location Visit Us Initiate Your Journey Toward Regulatory Excellence Your inquiries are important to us. Fill out the form below or call us to discuss your pharmaceutical regulatory requirements. Our team is ready to provide the guidance and services you need. First name* Last name* Email* Phone Are you a healthcare professional?* Yes No Other What services are you interested in?* ​Regulatory Intelligence Sales and Marketing Section 21 Import & Export Services New Business Development Other Subject Message I aknowledge and accept MC Pharma's T&C's and Privacy Policy Submit Get in Touch FAQ's Quick Answers to Your Queries Who are the leading pharmaceutical regulatory companies in South Africa? The South African Health Products Regulatory Authority (SAHPRA) is the regulatory authority of South Africa responsible for the regulation of health products intended for human and animal use; the licensing of manufacturers, wholesalers, and distributors of medicines and medical devices; radiation emitting devices and radioactive nuclides; and the conduct of clinical trials . How do pharmaceutical regulatory companies operate in South Africa? Pharmaceutical regulatory companies in South Africa are required to comply with the regulations formed by the South African Health Products Regulatory Authority (SAHPRA) . The Authority requires that a pharmaceutical manufacturer or wholesaler be licensed to manufacture, which may include a licence to import and/or export medicines, or to act as a wholesaler of medicines. Guidelines are issued by the Authority, from time to time, which relate to various matters including Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP). All pharmaceutical manufacturers and wholesalers are required to comply with such guidelines . What are the challenges faced by pharmaceutical regulatory companies in South Africa? The pharmaceutical regulatory environment in South Africa is complex and influenced by the country’s socio-economic paradigm. Some of the challenges faced by pharmaceutical regulatory companies in South Africa include poor regulatory environment, disparate regulatory requirements, uneven playing field, and inadequate financial resources . How do regulations impact pharmaceutical regulatory companies in South Africa? Regulations impact pharmaceutical regulatory companies in South Africa by requiring them to comply with the regulations formed by the South African Health Products Regulatory Authority (SAHPRA) . The Authority requires that a pharmaceutical manufacturer or wholesaler be licensed to manufacture, which may include a licence to import and/or export medicines, or to act as a wholesaler of medicines. Guidelines are issued by the Authority, from time to time, which relate to various matters including Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP). All pharmaceutical manufacturers and wholesalers are required to comply with such guidelines . What services do pharmaceutical regulatory companies offer in South Africa? Pharmaceutical regulatory companies in South Africa offer services such as strategic regulatory consulting, regulatory affairs and regulatory intelligence, registration pathways and license management services, end-to-end operational support, complete life cycle approach to CTD / eCTD dossier compilation and publishing, dossier preparation, review and management, regulatory submissions, medical writing, and more . How do pharmaceutical regulatory companies ensure drug safety in South Africa? Pharmaceutical regulatory companies in South Africa ensure drug safety by complying with the regulations formed by the South African Health Products Regulatory Authority (SAHPRA) . The Authority requires that a pharmaceutical manufacturer or wholesaler be licensed to manufacture, which may include a licence to import and/or export medicines, or to act as a wholesaler of medicines. Guidelines are issued by the Authority, from time to time, which relate to various matters including Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP). All pharmaceutical manufacturers and wholesalers are required to comply with such guidelines . What are the trends in pharmaceutical regulatory companies in South Africa? The trends and the market are changing constantly and an in depth and programmatic approach to analysing the data for each service and product requires an knowledgeable consultant to gather and compile. How do international pharmaceutical regulatory companies operate in South Africa? International pharmaceutical regulatory companies operate in South Africa by complying with the regulations formed by the South African Health Products Regulatory Authority (SAHPRA) . The Authority requires that a pharmaceutical manufacturer or wholesaler be licensed to manufacture, which may include a licence to import and/or export medicines, or to act as a wholesaler of medicines. Guidelines are issued by the Authority, from time to time, which relate to various matters including Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP). All pharmaceutical manufacturers and wholesalers are required to comply with such guidelines . What is the future of pharmaceutical regulatory companies in South Africa? The future of pharmaceutical regulatory companies in South Africa is expected to be influenced by the establishment of the African Medicines Agency (AMA) which will significantly contribute to the improvement of regulatory systems in the Africa region . How do pharmaceutical regulatory companies collaborate with drug manufacturers in South Africa? Pharmaceutical regulatory companies in South Africa collaborate with drug manufacturers by ensuring that they comply with the regulations formed by the South African Health Products Regulatory Authority (SAHPRA) . The Authority requires that a pharmaceutical manufacturer or wholesaler be licensed to manufacture, which may include a licence to import and/or export medicines, or to act as a wholesaler of medicines. Guidelines are issued by the Authority, from time to time, which relate to various matters including Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP).

  • Terms & Conditions | MC Pharma

    Terms & Conditions MC Pharma's Learn More Terms and Conditions Welcome to www.mcpharma.co.za (the "Website"). These Terms and Conditions ("Terms") govern your use of the Website operated by MCPharma (Pty) Ltd. ("us," "we," or "our"). Please read these Terms carefully before accessing or using our Website. By accessing or using any part of the Website, you agree to be bound by these Terms. If you do not agree to all the Terms, then you may not access the Website. ​ 1. Intellectual Property The content on this Website, including text, graphics, logos, images, audio clips, digital downloads, data compilations, and software, is the property of MCPharma (Pty) Ltd. and is protected by intellectual property laws. You may not use, reproduce, modify, distribute, or display any portion of this Website without our express written consent. ​ 2. User Responsibilities You agree to use the Website in accordance with all applicable laws and regulations. You are solely responsible for any content you submit to the Website and for ensuring that your use of the Website does not violate the rights of any third party. ​ 3. Account Information If you create an account on our Website, you are responsible for maintaining the confidentiality of your account and password. You agree to accept responsibility for all activities that occur under your account. You must notify us immediately if you believe that your account information has been compromised. ​ 4. Third-Party Links Our Website may contain links to third-party websites that are not owned or controlled by MCPharma (Pty) Ltd. We have no control over, and assume no responsibility for, the content, privacy policies, or practices of any third-party websites. You acknowledge and agree that MCPharma (Pty) Ltd. shall not be responsible or liable, directly or indirectly, for any damage or loss caused or alleged to be caused by or in connection with the use of or reliance on any such content, goods, or services available on or through any third-party websites. ​ 5. Disclaimer of Warranties The Website is provided on an "as-is" and "as-available" basis. MCPharma (Pty) Ltd. makes no warranties, expressed or implied, and hereby disclaims and negates all other warranties, including without limitation, implied warranties or conditions of merchantability, fitness for a particular purpose, or non-infringement of intellectual property or other violation of rights. ​ 6. Limitation of Liability In no event shall MCPharma (Pty) Ltd., its directors, officers, employees, or agents be liable for any indirect, incidental, special, consequential, or punitive damages, including without limitation, loss of profits, data, use, goodwill, or other intangible losses, resulting from (i) your use or inability to use the Website; (ii) any unauthorized access to or use of our servers and/or any personal information stored therein; (iii) any interruption or cessation of transmission to or from the Website; (iv) any bugs, viruses, trojan horses, or the like that may be transmitted to or through the Website by any third party; or (v) any errors or omissions in any content or for any loss or damage of any kind incurred as a result of your use of any content posted, emailed, transmitted, or otherwise made available via the Website, whether based on warranty, contract, tort, or any other legal theory. ​ 7. Governing Law These Terms shall be governed by and construed in accordance with the laws of South Africa. Any disputes arising under or in connection with these Terms shall be subject to the exclusive jurisdiction of the South African courts. ​ 8. Changes to Terms and Conditions MCPharma (Pty) Ltd. reserves the right to update, change, or replace any part of these Terms at any time. It is your responsibility to check this page periodically for changes. Your continued use of or access to the Website following the posting of any changes constitutes acceptance of those changes. ​ 9. Contact Information If you have any questions about these Terms, please contact us: By email: pharmacist@mcpharma.co.za By visiting this page on our website: https://www.mcpharma.co.za/contact Effective date: 01/01/2024

  • About MC Pharma: Your Regulatory Pharmaceutical Company

    Your Trusted Regulatory Pharmaceutical Company Pioneering Regulatory Excellence Prioritizing Patient Safety and Regulatory Compliance Embark on a journey with MC Pharma, a regulatory pharmaceutical company dedicated to steering your health products through the complex regulatory landscape in Africa. Our Mission MC Pharma serves as a reliable connection between pharmaceutical innovation and the global market, providing proactive assistance in a constantly evolving international landscape. We prioritize healthcare excellence, respect, and diversity, fostering collaboration and innovation for timely medication access and healthcare advancement. Simplifying Regulatory Complexities Our Vision Our commitment is to safeguard and enhance patient health by consistently delivering pharmaceutical products and services of the highest quality, ensuring safety and efficacy that meet global customer expectations. We achieve this through the implementation of current good manufacturing practices, cutting-edge technology, a skilled workforce, and efficient management practices. Fostering Growth Our Story About Us Global Footprint MC Pharma has over 25 years of regulatory experience. From being part of the genesis of a number of industry associations, to being at the forefront of regulatory legislative changes, MC Pharma has been intimately involved in every aspect. MC Pharma staff boasts experience in Retail Pharmacy, Hospital and the Research spheres of the pharmaceutical industry. A strong background in Academia is also reflected in MC Pharma’s diligent regulatory processes. We pride ourselves in being at the cutting edge of international regulatory changes to assist our customers pro-actively adapt to the ever changing requirements and regulations. Paired with extensive knowledge of the pharmaceutical industry as a whole, from SAHPRA (South African Health Products Authority) submissions to business growth and management, MC Pharma can adapt to the dynamic needs of the client. We endeavor to find innovative solutions to any aspect of the pharmaceutical regulatory process, and to assist our clients reach their goals in a dynamic international market. Company Profile Upholding Regulatory Standards Immerse in MC Pharma’s profile, reflecting a robust foundation in regulatory affairs, market analysis, and strategic partnerships, all tailored to ensure your successful market entry. Form Partnership We are dedicated to delivering high-quality products and services. 01 We uphold unwavering integrity in all our actions. 02 We firmly believe in transparent and open communication. 03 We are staunch advocates for the empowerment of our people, fostering entrepreneurship, innovation, and accountability. 04 We actively practice non-discrimination and provide equal opportunities for all. 05 We hold profound respect for individuals, society, and the environment. 06 Our Values What We Stand For Tracy Burger Executive Chairman of the Board Junita Castle Executive Finance and Logistics Jaco Van Der Wath Executive Sales and Marketing Declan Burger Executive Compliance Meet The Executive Team Committed to Excellence Our values of integrity, innovation, and partnership remain the compass that guides our actions, fostering a culture of trust, adaptability, and collaborative growth. Connect With Us Your Product Success, Our Priority Get in touch with our team of seasoned professionals to discuss how MC Pharma can accelerate your regulatory compliance and market entry journey in Africa. Meet The Team Our Employees Our employees constitute our most valuable asset. We hold in high regard the unique creativity of each individual employee and cultivate an environment that aligns with our core values. The Team Our Customers Our commitment is to surpass the requirements and expectations of our customers in terms of value, quality, and service through our products and services. We aim to instill confidence in our customers by consistently being a fair and reliable partner. Surpass Expectations

  • Your Inquiry Has Been Received | MC Pharma

    Thank You Return Home Our Services One of our consultants will reach out to you as soon as possible. Have a great day.

  • Pharmaceutical Regulatory Services | Access to Africa | MC Pharma

    Regulatory Compliance Comprehensive Pharmaceutical Regulatory Services Your Partner in Achieving Market Compliance Discover a suite of pharmaceutical regulatory services meticulously designed to navigate the complex African market landscape. From Registration Strategies to Marketing & Sales, our modular services are meticulously crafted to align with your market entry and growth aspirations. Tailored for Your Success Our Service Spectrum All Services ​Regulatory Intelligence Regulatory Consulting and Quality Assurance MC Pharma (Pty) Ltd is licensed under Section 22C(1)(b) of Act 101 (the Medicines and Related Substances Act 101, of 1965), and conducts various services to assist entities in operating the medical industry. Regulatory affairs consultancy and registration services include, but not limited to: Learn More New Business Development ​Business Development Services Proactively seeking new business opportunities. Research new opportunities and manage the company entry and development strategy. Building business relations with current and potential clients. Doing extensive research on all potential markets, products and potential clients. Liaison with client and regulatory bodies for registration of products. Maintaining short- and long-term business development plan. Learn More Section 21 ​Authorisation Granted by SAHRPA MC Pharma can assist with import and supply of unregistered orthodox medicine or veterinary medicine into Africa on a Section 21 basis. Learn More Import & Export Services Distribution & Wholesale MC Pharma has agreements with major distributors and wholesalers: Import and Export logistics. Management of local warehousing and distribution. Key Accounts Liaison. Learn More Sales and Marketing Sales & Marketing Team Sales reporting and analysis. Development of Marketing aids to suit Reps needs. Documentation and detailing of products, new product launches in market. Advertising Compliance and Certification. Dedicated and experienced sales reps. Marketing and design. Market analysis. Learn More Our Products Suite Compliant, Reliable, and Market-Ready Explore our range of products, each engineered to meet the rigorous regulatory standards of the pharmaceutical landscape in South Africa. Our Products Medical Products Explore our range Medical products already approved for South African market. Our Products Adverse Drug Reactions Prioritizing Patient Safety and Regulatory Compliance Adverse Drug Reactions (ADRs) are a critical concern in the pharmaceutical industry. MC Pharma places paramount importance on understanding, managing, and reporting ADRs to ensure patient safety and adhere to regulatory standards for products registered on our license. Learn More Strategic Partnering With the Future in Mind Our aim is to become your strategic partner by understanding your strategic objectives, identifying the critical aspects of your business plans and matching the appropriate solutions to those plans Our Partners

  • Pharmaceutical Import, Export and Distribution into Africa | MC Pharma

    Seamless African Market Entry Your Trusted Partner in Imports & Exports Let Us Navigate Africa for You Navigate the African pharmaceutical market with ease through MC Pharma’s adept Import and Export services, tailored to ensure a seamless market entry and compliance. Import and Export Logistics Send Management of Warehousing Send Distribution Management Send Key Accounts Liaison Send Get in touch with our team of seasoned professionals to discuss how MC Pharma can accelerate your pharmaceutical market entry in South Africa through adept imports and exports services. Beyond the Basics Understand Your Import and Export Journey Contact Us

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