DI Regulatory Consultants

Regulatory Services

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, Zimbabwe, 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.

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.

Related links

South African Health Products Regulatory Authority (SAHPRA)

www.sahpra.org.za

South African Pharmacy Council

www.pharmcouncil.co.za

 

National Department of Health

www.health.gov.za

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