Pharmaceutical & Biological Medicines
Pharmaceutical and Biological Medicines are subject to registration in terms of The Medicines and Related Substances Act; Act 101 of 1965, as amended.
There are particular requirements and processes involved during the registration process for medicines in South Africa and other African Territories.
We offer the following services:
- Due Diligence and guidance related to registration dossiers for New Chemical Entities (NCE’s), Multisource Medicines, Biologicals and Biosimilars
- Dossier compilation for applications for registration
- Dossier amendments/variations, updates & maintenance
- Professional Information/Summary of Product Characteristics, Patient Information Leaflets and Labels – writing and review
- Guidance and advice on current Good Practice (cGxP) expectations
- Self-Inspections & 3rd-Party Compliance Audits
- Design and Implementation of Quality Management Systems
- Writing of Standard Operating Procedures
- Writing of Site Master Files
- Licensing applications
- Dossier Conversions from Legacy formats including creation of eCTD Baselines
- Creating Variation (Amendment) applications
- Compilation of registration dossiers for submission into Africa and, or the various joint review initiatives (Zazibona | WHO).