JJ Pharma offer a secure, reliable stability sample storage facility for all pharmaceutical forms, as well as comprehensive regulatory service.
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.
- Registration of products – updates – variations (South Africa and Sub-Saharan Africa)
- Advertising compliance (reviewing of any marketing or advertising material to ensure that it complies with regulations)
- Regulatory liaison services
- Creating informational leaflets and package inserts
- Outlining requirements for labelling, storage and packaging
- Regulatory information review with gap analysis reports
- Registration dossier life cycle management
- Licensing for Manufacturer/Wholesale/Distribution
- eCTD technology (to save on registration costs and manage time constraints):
- Due diligence
- ZA CTD submissions
- Compiling eCTD dossiers
- Responses to the SAHPRA
We are equipped to collect and deliver product samples safely and securely to and from you or a laboratory of your choice.
- Monthly updates, including graphs and statistical reports are provided.
- The data generated is securely backed up on, and off-site.
- Access to our server is password-protected to ensure data integrity and confidentiality, to comply with local and international requirements.
- All of the documentation we provide complies with SAHPRA, ICH and WHO format requirements.
- In the case of any irregularities in temperature or humidity conditions, we receive an immediate notification. Our qualified technician is on call 24-hours a day to take immediate corrective action.
Storage of product samples in stability chambers at specified temperature and humidity conditions:
- 25 ± 2 ̊C/ 60 ± 5 % Relative Humidity
- 30 ± 2 ̊C/ 75 ± 5 % Relative Humidity
- 40 ± 2 ̊C/ 75 ± 5 % Relative Humidity
We offer English to Afrikaans translation services for professional information and patient information leaflets.