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- Application of CTD, eSubmission and eCTD for Orthodox Medicines- New Chemical Entities, Biologicals, Biosmilars, Vaccines.
- Application of CTD, eSubmission and eCTD for Orthodox Medicines- Generics based on Bioequivalent studies, clinical data and biowavers.
- Application of CTD for Complementary Medicines (CMs).
- Application for registration approval in Sub-saharan countries including Namibia, Botswana, Mauritius, Zimbabwe, Angola, Zambia, Kenya, Uganda, Ghana, Nigeria etc.
- Due diligence on dossier information.
- Phamaceutical Variations including full conversations from MBR1 and MRF1 to current eSubmissions and eCTD format.
- Application for registration approval of veterinary medicines under Act 101 and Act 36.
- Licence application for applicant for manufacturer, applicant, laboratories, wholesalers (NDOH, SAPC, SAHPRA).
- Application for licence approval for medical device companies.
- Standard Operating Procedures (SOPs).
- Auditing of Facilities (cGMP, GLP, GWP).
- Review and proofreading of labeling artwork and advertising material.
- Overall regulatory due diligence of the business.
