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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.

blue 3d capsules for adverse drug reactions
green 3d regulatory affairs document


Compiling and submission of ZA-eCTD applications for Medicines, Medical Devices and Health Products


eCTD compilation, submission and full CTD life-cycle management including updates and amendments.


Package insert and patient information leaflet development.


Registration gap-analysis data reporting.


Site Master File (“SMF”) in accordance with the Preparation of a Site Master File Guideline (4.08).


Import/Export and Distribution logistics of regulated pharmaceuticals


Development of Quality Management System (“QMS”) in compliance with GLP


Quality Manual


Standard Operating Procedures


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.

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.

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.

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


Your Queries Addressed


We purchase the stock


We import the stock


We pay the yearly retention fees to SAHPRA


We will share all the post importation testing and transport validation reports with the principle


Adverse reactions (PV) report will be sent to DRCONSULTING and the principle


We are liable to keep the dossier updated as to SAHPRA requirements

If MC Pharma Has Sole Distribution Rights

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