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Application of CTD, eSubmissions and eCTD for Orthodox Medicines- New Chemical Entities, Biologicals, Biosmilars, Vaccines.
Application of CTD, eSubmissions 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.

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