DI Regulatory Consultants
We provide the following services:
- Due diligence on dossier information.
- Application of ZACTD and eCTD for Orthodox Medicines – New Chemical Entities, Biologicals, Biosimilars, Vaccines.
- Application of ZACTD 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 ZACTD and eCTD for Complementary Medicines.
- Application of MRF applications for Veterinary Medicines in terms of Act 101, as well as applications with DAFF
- Applications for registration approval in English speaking Sub-Saharan countries including Namibia, Botswana, Mauritius, Zimbabwe, Angola, Zambia, Kenya, Uganda, Ghana, Nigeria etc.
- Pharmaceutical Variations including full conversions from MBR1 and MRF to current ZA CTD and eCTD format.
- Safety and PV updates to professional information and patient information leaflets.
- Application of IVDs 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 (SOP’s)
- 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, cosmetics.
- Regulatory Due diligence on companies.
- Assistance with stability and validation protocols
- Assistance with analytical method transfers and verification.
Applicant/holder of registration certificate
LeBasi Pharmaceuticals was founded in 1998 to act as an applicant on behalf of local and international companies. LeBasi Pharmaceuticals has a manufacturing import/export licence.