Pharmaceutical & Biological Medicines

Pharmaceutical and Biological Medicines sold in South Africa are subject to registration in terms of The Medicines and Related Substances Act; Act 101 of 1965, as amended.

We offer the following services for South Africa and other African Territories:

  • Due Diligence and guidance related to registration dossiers for New Chemical Entities (NCE’s), Generics/Multisource Medicines, Biologicals and Biosimilars
  • Dossier compilation for applications for registration
  • Dossier amendments/variations, updates & maintenance
  • Package inserts, patient information leaflets, label compilation and review
  • Guidance and advice on current Good Practice (cGxP) expectations & implementation planning
  • Self-Inspections & 3rd Party Compliance Audits – cGxP, including GPvP
  • Design and Implementation of Quality Management Systems
  • Compilation of Standard Operating Procedures
  • Compilation of Site Master Files
  • Licensing applications
  • Advertising and Marketing Code compliance
  • Dossier Conversions from Legacy formats
  • Regulatory writing services
  • Registration dossiers for submission into Africa and, or the various joint review initiatives.

 

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