• 263 242 331356/7
  • info@orangehealth.co.zw, sales01@orangehealth.co.zw

Regulatory Affairs

We provide the following services:

- Due diligence on dossier information

- Application of CTD and eCTD for Orthodox Medicines – New Chemical Entities, Biologicals, Biosimilars, Vaccines.
- Application of CTD and eCTD for Orthodox Medicines – Generics based on Bioequivalent studies, clinical data, biowaivers in terms of BCS classifications, dosage forms as well as literature-based applications.
- Application of CTD for Complementary Medicines (CMs).
- Application for Veterinary Medicines under Act 101, as well as Act 36 applications to Department of Agriculture, Forestry and Fisheries (DAFF).
- Applications for registration approval in English speaking Sub-Saharan countries including Namibia, Botswana, Mauritius, Angola, Zambia, Kenya, Uganda, Ghana, Nigeria etc.
- Pharmaceutical Variations including full conversions from MBR1 and MRF1 to current eSubmission and eCTD format.
- Safety and pharmacovigilance (PV) updates to professional information (PI) and patient information leaflets (PIL).
- Application of IVDs and Medical Devices as per current SAHPRA guidelines.

- Assisting with formation of companies, Licence Applications (SAPC, DOH & SAHPRA) for manufacturers, applicant import/export, wholesalers and distributors.
- Licence Applications for Medical Device companies – manufacturers, importers, distributors.
- Auditing of all Facilities including API manufacturers (Current GMP, GLP, GWP and GCP).
- Standard Operating Procedures (SOPs)
- Quality management system SOPs and systems based on ISO 13485 for Medical Device companies.
- Translations and proofreading of artwork and advertising material.
- Review and compilation of labels for Health Supplements, Complementary Medicines and Cosmetics.
- Regulatory due diligence on companies.
- Assistance with stability and validation protocols.
- Assistance with analytical method transfers and verification.
- Appeals.

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