Orthodox / Allopathic Medicines
Orthodox / Allopathic 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 we offer the following services:
- Review of product information for registration dossiers for New Chemical Entities (NCE's) and generic products
- Dossier compilation for medicine registration
- Dossier updates & maintenance
- Package inserts, patient information leaflets and label compilation and review
- Guidance and advice on cGMP/cGDP/cGWP
- Vendor audits
- Compilation of Standard Operating Procedures
- Compilation of Site/Applicant/HCR Master Files
- Licensing applications
- Advertising and Marketing Code compliance
The successful registration of a medicine lies mainly in the ability to prevent unnecessary delays during the process. This is achieved by understanding the process pitfalls. We aim to present a quality submission that will avoid undue hold-ups during the registration process.
We compile eCTDs for our clients which are published and printed to paper, as required for the current registration process. The electronic documents can at any time be re-published as eCTDs, should the MCC change its requirements from paper to electronic. This provides great flexibility to our clients as it allows them to import validated eCTDs into their document management systems for future use and life-cycling of their dossiers.
