About MC Pharma & Guna

Situated between Johannesburg and Pretoria in South Africa, MC Pharma has been serving multinational and generic companies with the necessary regulatory expertise for business expansion and growth for more than 2 decades.

We pride ourselves in developing customer-centric solutions in line with our partner’s goals.

Our team boasts experience from within South Africa as well as expertise having worked in international regulatory environments in the UK.

Our Service Offerings

  • Feasibility; market orientation and competitive positioning reports Regulatory impact assessment.
  • Registration strategy
  • MC Pharma is a pre-registration contract Applicant / Prospective Holder of the Certificate of Registration
  • Portfolio includes: NCE’s Generics / Multisource Medicines, Biologicals, Biosimilars, Veterinary Medicines and Complementary medicine.
  • Due diligence on registration documents.
  • Dossier complication: CTD / eCTD.
  • Package inserts, patient information leaflets, label compilation and review.
  • Complication of Standard Operating Procedures, Site Master files and License applications, where required.
  • MC Pharma acts as the Holder of Certificates of Registration (HCR) for registered medicines.
  • Robust Quality Management System.
  • Finished Product Release.
  • Responsibility.
  • Product Quality monitoring and Reviews.
  • Dossier amendments / variations and life-cycle management.
  • Quality audits; GMP compliance; Self-Inspections and 3rd Party Compliance Audits.
  • Design, certification and approval of printed packaging materials.
  • Pharmacovigilance.
  • Post-Marketing surveillance.
  • Trained and specialised sales force with a national footprint.
  • Training of Representatives according to the Marketing Code and Regulations.
  • Compliance certification of adverts and marketing aids.
  • In-house marketing service.
    Sales data recording and analysis.
  • Established relationships with wholesalers (34) and distributions (4) facilities.
Regulations Compliance Policies

Our Service Offerings

We are proud to represent, and service global customers and principals such countries as

MC Pharma is MAH for

New Business Opportunities

Should you wish to join our company, or feel the need to connect with us to explore New business opportunities, please contact us.

Address: 62, Constantia Avenue, Mnandi, Centurion

Telephone: +27 (0)12 668 3019

Email: pharmacist (at )

Visit our Company Website at: