Registration of pharmaceutical and biological products, complementary medicines, and Health and nutritional supplements. Pharmakine Ltd understands the registration landscape in the African markets and we have firsthand experience working with National Medicines Regulatory Authorities (NMRAs) in Africa. We have a team with many years of experience in dossier compilation, filing, and registration. We are familiar with SAHPRA/MCC (South Africa), MCAZ (Zimbabwe), Zazibona (Zambia, Zimbabwe, Botswana, Namibia), Tanzania FDA, Uganda FDA, Ghana FDA, NAFDAC (Nigeria), EFMHACA (Ethiopia) and Kenya Pharmacy and Poisons Board (KPPB) and many others.
- Serve as local agent for registration and market authorization
- Provide expert guidance on registration requirements of countries
- Review dossier for completeness based on country guidelines prior to submission and address gaps in product dossier, where they exist
- Compile dossier according to CTD format prior to submission
- Provide guidance to sponsor to address queries from regulatory authority and follow the progress of the dossier to ensure timely regulatory approval
- Develop the PI, PIL and label in accordance with local guidelines
Marketing and Distribution.
Marketing and distribution of health products including medicines & diagnostics.
Pharmakine Ltd. through its subsidiary (Pharmaply Limited) market and distribute products in Africa. Pharmaply Limited owns a warehouse in the Gezina area of Pretoria, South Africa, from where it stocks and distributes generic products to wholesalers and pharmacies in Africa.
- Partner with in-country distributors to create distribution channels in identified African markets
- Deploy and support local marketing and sales force to reach prescribers and pharmacies to be responsive to the needs of local markets
- Design relevant marketing material and reach key medical opinion leaders
- Re-packaging from bulk imports for local distribution
- Conduct market research and analysis to enable data-driven business decisions throughout the product life-cycle
Technology transfer to promote local manufacture
- Identify strategic local and foreign partners and negotiation skills and technology transfer
- Working with local government agencies, identify incentive schemes to facilitate technology transfer and localization
Training & Consulting.
- Provide hands-on training in dossier compilation, evaluation and submission processes
- Consult on policy formulation and programmatic reviews
- Conduct market research and compiling market intelligence data
- Train and manage local marketing and sales force
- Identify and conduct due-diligence on competent international consultants in the areas of facility design and qualification, cleaning validation, formulation development, pharmaceutical facilities, GMP/GLP/GCP, BE study design and conduct.
Pharmaceutical, Biotech, Herbal and Food Analytical Services.
- Provide local testing for post-importation compliance
- Design and conduct BA/BE bioanalytical studies to fulfill local pharmacogenetic requirements and generate PK data
- Provide quality testing for Dissolution studies; Water content analysis; Uniformity of pharmaceutical content; Pharmacokinetics (BABE); Drug stability tests (for re-test and shelf-life determination); Pesticide and residual chemical analysis; Chemical contaminants including mycotoxins (e.g. aflatoxins) and heavy metals; Phytochemical analysis for chemical biomarkers and actives; Testing for anti-oxidants, food additives and preservatives; Sugars enzymes and total nutrient analysis