Address: PO box 336 Wierda Park 0149 South Africa

Tel: +27 (0)12 668 3021

Web: http://www.mcpharma.co.za/

Company description

MC Pharma (Pty) Ltd., is a 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.

MC Pharma does not own, wholesale or distribute product and the Principal is at all times deemed to be the owner of the medicinal product(s). Commercialisation activities are delegated, by means of agreements, to competent and licenced companies in South Africa, with the approval of the Principal or product owner.

MC Pharma is proud to represent, and to service global customers and Principals from such countries as Australia, the USA, Brazil, EU and UK.

Products and services

SERVICES INCLUDE:

1. Reviewing formulation ingredients for claim and labeling compliance;
2. Advertising compliance: avoid the embarrassment and consequences of having a
published advertisement found to be in conflict with local requirements.
We screen promotional material giving confidence that marketing and advertising
complies with local regulatory standards;
3. Regulatory liaison with the Regulatory Authority(ies);
4. GMP and Quality Assurance consultations;
5. GMP assessments of manufacturing, packaging and distribution facilities;
6. Technical agreements with 3rd party contractors: we will facilitate in the setting up of
and establishing the required technical agreements with: –

• Manufacturers and Packers,
• Laboratories,
• Warehouses,
• Distributors,
• Printers,
• Advertising agencies
• Marketing Agencies

7. Pharmacovigilance

OTHER SERVICES INCLUDE:

In-licensing of products for local commercialisation utilizing Marketing Authorisations under MC Pharma’s name;
Facilitation of product acquisition, including the evaluation of registration dossiers and supporting regulatory and registration documentation;
Product feasibility and positioning;
Market assessment and analysis
Commercialisation of product including marketing;
Representative training