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Trusted regulatory company specialising in pharmaceutical compliance, product registration, and effective market entry solutions tailored for the African market. 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 Vision Fostering Growth 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. Our Mission Simplifying Regulatory Complexities 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. Our Customers Surpass Expectations 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. Our Employees The Team 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. Our Values What We Stand For 01 We are dedicated to delivering high-quality products and services. 02 We uphold unwavering integrity in all our actions. 03 We firmly believe in transparent and open communication. 04 We are staunch advocates for the empowerment of our people, fostering entrepreneurship, innovation, and accountability. 05 We actively practice non-discrimination and provide equal opportunities for all. 06 We hold profound respect for individuals, society, and the environment. 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 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. MC Pharma (Pty) Ltd., is a specialist pharmaceutical company licensed in terms of Section 22C of the Medicines and Related Substances Act 101 of 1965, and offers the services of an Applicant and Holder of the Registration Certificate (Marketing Authorisation Holder), on behalf of a Principal or Product Owner. MC Pharma has a combination of local licenses (DoH, SAPC, SAHPRA) thereby enabling us to act as contract Marketing Authorisation Holder (MAH) and local SAHPRA liaison on behalf of a principal or product owner. Services offered: Regulatory Intelligence Sales and Marketing Section 21 Application Import and Exports New Business Development MC Pharma has, in addition to our local Clients, a wealth of global Clients in countries such as the UK, Australia, France, Germany, Brazil, China, India, Israel, China, and the USA. We endeavor to find innovative solutions in an ever-changing international market to assist our clients in reaching their goals. MC Pharma has a national sales footprint and we cover the entire African market (South Africa, Namibia, Lesotho, Botswana and Swaziland), as well as most countries upon inquiry. MC Pharma distributes through outsourced Distributors and Wholesalers. We have long-standing and trusted, pre-approved, relationships with reputable Distributors and 2 Wholesalers in Africa. 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. 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 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 Why should I hire pharmaceutical regulatory affairs consultants? Consultants simplify complex regulatory processes, ensuring quicker and compliant market entry in Africa. How do consultants help with SAHPRA submissions? Consultants prepare and submit detailed dossiers to SAHPRA, managing communication and approvals. Do regulatory consultants handle ongoing compliance? Yes, they offer ongoing compliance monitoring, audits, and post-market surveillance. Can consultants help with product launches? MC Pharma assists with regulatory strategies and compliance for new product launches. What experience does MC Pharma have as regulatory consultants? MC Pharma has 26+ years' regulatory consulting experience.

Partner with regulatory experts specialising in compliant market entry and strategic growth solutions for pharmaceutical companies expanding into South Africa. 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 Get in Touch 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 Import & Export Services New Business Development Other Subject Message I aknowledge and accept MC Pharma's T&C's and Privacy Policy * Submit Our Office Location Book Your Personal Consultation With 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. Visit Us 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). Why should I hire pharmaceutical regulatory affairs consultants? Consultants simplify complex regulatory processes, ensuring quicker and compliant market entry in Africa. How do consultants help with SAHPRA submissions? Consultants prepare and submit detailed dossiers to SAHPRA, managing communication and approvals. Do regulatory consultants handle ongoing compliance? Yes, they offer ongoing compliance monitoring, audits, and post-market surveillance. Can consultants help with product launches? MC Pharma assists with regulatory strategies and compliance for new product launches. What experience does MC Pharma have as regulatory consultants? MC Pharma has 26+ years' regulatory consulting experience.

eCTD Publishing & Regulatory Submissions | SAHPRA-Compliant eCTD Services for Faster Approvals & Seamless Compliance Regulatory Information Management (RIMs) Efficiently Manage Regulatory Data Across the Product Lifecycle Regulatory Information Management (RIM) is essential for pharmaceutical, healthcare, and medical device companies to efficiently handle regulatory submissions, compliance, and approvals. Our RIM system allows for seamless tracking, document storage, and submission management, ensuring you meet evolving regulatory requirements without delays. Key Features of Our RIM System: Centralized Regulatory Data Management: Keep all compliance documents organized in one system. Automated Workflows & Version Control: Ensure consistency and accuracy across all submissions. Real-Time Tracking & Audit Trails: Monitor submission status and regulatory interactions. Seamless Integration with eCTD: A unified approach to managing compliance and lifecycle updates. By implementing RIM solutions, companies can streamline regulatory processes, reduce risks, and improve overall compliance management. electronic Common Technical Document (eCTD) eCTD Publishing & Regulatory Submissions Simplify Compliance with Expert eCTD Services Managing electronic Common Technical Document (eCTD) submissions can be complex, but our streamlined services ensure compliance, accuracy, and efficiency. MC Pharma offers end-to-end eCTD publishing and e-submission solutions, helping you navigate regulatory requirements with ease. Whether submitting to SAHPRA, BoMRA, NMRA, or other authorities, we ensure seamless document preparation, validation, and lifecycle management. Let Us Assist Why should I hire pharmaceutical regulatory affairs consultants? Consultants simplify complex regulatory processes, ensuring quicker and compliant market entry in Africa. How do consultants help with SAHPRA submissions? Consultants prepare and submit detailed dossiers to SAHPRA, managing communication and approvals. Do regulatory consultants handle ongoing compliance? Yes, they offer ongoing compliance monitoring, audits, and post-market surveillance. Can consultants help with product launches? MC Pharma assists with regulatory strategies and compliance for new product launches. What experience does MC Pharma have as regulatory consultants? MC Pharma has 26+ years' regulatory consulting experience. Key Benefits of eCTD Implementation Faster Approvals, Improved Compliance, and Cost Savings 01. Improved Efficiency & Automation Streamlines regulatory submissions with automated workflows, reducing manual workload and errors. 02. Regulatory Compliance & Validation Ensures submissions meet SAHPRA, BoMRA, NMRA, and global regulatory standards with built-in compliance checks. 03. Better Document Organisation Standardised eCTD structure simplifies document management, tracking, and version control. 04. Enhanced Collaboration Centralised data allows seamless communication between teams, regulatory agencies, and stakeholders. 05. Cost & Time Savings Eliminates printing, shipping, and administrative costs while accelerating regulatory approvals. 06. Transparency & Audit Readiness Maintains a clear submission history and audit trails for compliance reviews. 07. Scalability & Flexibility Easily manage large and complex dossiers while adapting to changing regulatory requirements. 08. Real-Time Tracking & Monitoring Provides instant updates on submission status, approvals, and compliance progress. 09. Global Regulatory Alignment Harmonised submissions support market expansion and faster approvals in multiple regions. 10. Faster Time-to-Market Reduces approval timelines, helping companies launch products more quickly and gain a competitive edge.

Latest Insights and Updates Pharmaceutical Regulatory News Your Trusted Source for Pharmaceutical Regulatory News Explore a wealth of Pharmaceutical Regulatory News, encompassing policy changes, regulatory advancements, and industry trends, curated meticulously to provide you with a reliable source of latest updates. Coming Soon 31 May 2024 Stay Tuned Read More Coming Soon 31 May 2024 Stay Tuned Read More Coming Soon 31 May 2024 Stay Tuned Read More Coming Soon 31 May 2024 Stay Tuned Read More Coming Soon 31 May 2024 Stay Tuned Read More Coming Soon 31 May 2024 Stay Tuned Read More Find Topics of Interest Easy Navigation Through Regulatory News Utilize our categorized and searchable news database to find specific topics or regulatory updates of interest, making it easier to access the information you need. Never Miss an Update Stay informed and ahead in your field by subscribing to MC Pharma’s news feed. Receive the latest Pharmaceutical Regulatory News directly in your inbox, ensuring you never miss an important update. Subscribe to Our News Feed First name* Last name* Email* Stay Connected Have Questions? Reach Out to Our Regulatory Experts For any inquiries or further clarification on Pharmaceutical Regulatory News, feel free to contact our regulatory experts. We are here to assist and provide the insights you need. Contact Us

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News Title 05 News Title 05 28/02/23, 22:00 This is a paragraph. It is connected to a CMS collection through a dataset. Click “Edit Text” to update content from the connected collection. This is a paragraph. It is connected to a CMS collection through a dataset. Click “Edit Text” to update content from the connected collection. Previous Next