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.
- MC Pharma was established in 1995 and started marketing Guna injectable collagen in 2021.
- Pharmaceutical licensed company (in terms of Section 22C of the Medicines and Related Substances Act 101 of 1965),
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MC Pharma offers both regulatory, consulting and commercial services to the pharmaceutical industry.
As a registered pharmaceutical company, we also have our own products which we market and distribute in South Africa and neighbouring countries.
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.
Our Service Offerings
We are proud to represent, and service global customers and principals such countries as
- USA (Bell, Organogenisis, Legendary Milk)
- Spain (SAG manufacturing)
- Germany (Karma Pharmatech GmbH; MEDCE Arzneimittel Pütter GmbH & Co. KG; Syntacoll Manufacturing)
- SERB Speciality Pharmaceuticals
- Canada (Factors Group of Nutritional Companies)
- South Africa (Colgate Palmolive; PES; RiteAid; Slenderwonder; Tomarmed; Voluplex; Xie's Import & Export; ZimmerBiomet).
- Parexel International
- ACRO – African Clinical Research Organisation
MC Pharma is MAH for
- Controlled veterinary narcotics such as M99/M5050 [S6] on behalf of Voluplex
- Registered medicines such as Inapsin, RetinA. Zarontin, Quadriderm, Periactin, Garacoll, Skabi-Rid lotion
- Medical Device companies e.g. ZimmerBiomet for Septopal and Refobacin
- Animal Health companies e.g. Bell and PES
- Selected complementary clients e.g. Closmeyer, Legendary Milk and Factors Group
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 ) mcpharma.co.za
Visit our Company Website at:
