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.
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Compiling and submission of ZA-eCTD applications for Medicines, Medical Devices and Health Products
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eCTD compilation, submission and full CTD life-cycle management including updates and amendments.
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Package insert and patient information leaflet development.
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Registration gap-analysis data reporting.
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Site Master File (“SMF”) in accordance with the Preparation of a Site Master File Guideline (4.08).
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Import/Export and Distribution logistics of regulated pharmaceuticals
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Development of Quality Management System (“QMS”) in compliance with GLP
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Quality Manual
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Standard Operating Procedures
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Application for South African National Accreditation System (SANAS) GLP Certification
Regulatory and Quality Assurance
FAQ's
Your Queries Addressed
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.
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.
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.
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.
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.
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.
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We purchase the stock
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We import the stock
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We pay the yearly retention fees to SAHPRA
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We will share all the post importation testing and transport validation reports with the principle
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Adverse reactions (PV) report will be sent to DRCONSULTING and the principle
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We are liable to keep the dossier updated as to SAHPRA requirements
