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Pioneering Regulatory Excellence
eCTD Management
Regulatory Pharmaceutical Services
Proactive Pharmacovigilance
Your Trusted Regulatory Pharmaceutical Company

Pioneering Regulatory Excellence

Prioritising 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 Affiliations

Our affiliations from reputable bodies affirm our competence and commitment to adhering to the highest standards of regulatory compliance.

National Department of Health
Pharmaceutical Society of South Africa - PSSA
Marketing Code Authority
Electronic Common Technical Document - eCTD
Generic and Biosimilar Medicines of Southern Africa (GBM)
Self-Medication Manufacturers Association of South Africa
South African Pharmacy Council (SAPC)
The South African Medical Technology Industry Association (SAMED)
Health Products Association of South Africa
Southern African Pharmaceutical Regulatory Affairs Association (SAPRAA)
The Self-Care Association of South Africa

Who We Are

Expertise Rooted in Experience

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.

Vaccine Production Line with glass vials and automated arms

Our Service Spectrum

Tailored for Your Success

From Registration Strategies to Marketing & Sales, our modular services are meticulously crafted to align with your market entry and growth aspirations.

eCTD Management

Publishing & Submissions

Let us help you e-publish and e-submit your regulatory dossiers

eCTD regulatory management and tracking
Pharmaceutical researcher working with laboratory microscope and dossiers

Industry Insights

Stay Updated, Stay Ahead

Dive into the latest updates and trends in the pharmaceutical industry to keep your operations compliant and competitive.

Adverse Drug Reaction Reporting

Ensuring Patient Safety

Report adverse drug reactions promptly, aiding in the continuous effort to uphold patient safety and product efficacy.

Allergic reaction rash on neck and shoulder
Clinical allergy scratch test on arm with markings
Laboratory test tubes with green solutions

Our Partners

Collaborative Growth

Meet our global partners who have leveraged MC Pharma's expertise for successful market entry and regulatory compliance in Africa.

Our Global Footprint

International Collaborations

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.

In addition to our local Clients, a wealth of global Clients in countries such as the UK, Australia, France, Germany, Brazil, China, India, Israel, and the USA.

We endeavor to find innovative solutions in an ever-changing international market to assist our clients in reaching their goals.

A green dotted MC Pharma world map with various countries on it
Doctor with stethoscope taking notes on clipboard

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.

Frequently asked questions

Pharmaceutical Regulatory Affairs Consultants

Consultants simplify complex regulatory processes, ensuring quicker and compliant market entry in Africa.