Our aim is to co-develop customer specific solutions in line with their company goals to achieve successful market entry into the South African and Sub-Saharan pharmaceutical and healthcare market.
MC Pharma Consulting has extensive regulatory experience and in-depth involvement in all spheres of industry. From being part of the most industry associations, to being at the forefront of regulatory legislative changes, MC Pharma Consulting is intimately involved in every aspect of medicine.
Regulatory affairs consultancy and registration services include, but not limited to:-
* compiling and submission of ZA-CTD applications for Orthodox Products, Medical devices and all Complementary healthcare products;
* eCTD compliation, submission and full CTD life-cycle management including updates and amendments.
* package insert and patient information leaflet development.
* registration gap-analysis data reporting.