JJ Pharma assist pharma companies with setting up regulatory systems as per the SAHPRA Regulator’s requirements.
One size does not fit all
We quote based on an understanding of each client’s requirements, are competitively priced and can accommodate once-off or monthly billing.
We’d like to talk to you about what exactly you need.
- CTD/eCTD Compilation
Compile registration documents as per Authority’s regulatory standards for Pharmaceuticals, Complementary Medicines and Medical Devices.
- Due Diligence
Perform due diligence and guidance on existing and new dossiers with gap analysis reports.
- Life Cycle Management of CTD dossiers
Manage dossiers during the pre- and post-registration stages. Submit registration variations (updates & maintenance) throughout the product’s lifecycle.
- eCTD Capabilities
Utilisation of eCTD technology. Compile and publish eCTDs for existing and new products.
- PI, PIL & Label
Draft Professional Information (PI), Patient Information Leaflets (PIL) and labels in accordance with the latest regulatory requirements.
Translate PI, PIL and label from ENGLISH into AFRIKAANS.
- Pharmacovigilance & Product Recalls
Monitor the product in the market and assist with product recall based on the outcome of the investigations.
Regulatory liaison with Regulatory Authorities
- Deputy Responsible Pharmacist (RP)
Perform the functions of the RP in the absence of the RP.
- Final Product Release
Review product batch documentation, analytical data and finished packed product prior to release to the market.
- Annual Product Review
Review and provide a report for each product by assessing the manufacturing/packing documents, analysis results, complaints and any trends.
- Stability Studies
Coordinate set-up and execution of stability studies.
- Liaison with 3rd party contractors
Liaise with 3rd party contractors (manufacturers, packers, laboratories) as required for the different processes, studies and testing.
- Licence Applications
Assist with application of manufacturing, import/export/distribution and wholesale licences for pharmaceuticals, complementary medicines and medical devices.
- Advertising compliance
Reviewing of any marketing or advertising material to ensure it complies with regulations.
We offer English to Afrikaans translation services for professional information and patient information leaflets.