Services
Pharmaceutical Industry
Consultancy
As consultants, we offer services on regulatory compliance and support with pre-clinical developments, clinical trials, regulatory submissions, pharmacovigilance and many aspects to support your services and product lifecycle management.
We help develop global product quality and regulatory dossier for submission to regulatory authorities for approvals and product market authorisations and licences.
We help organisations design, development and implementation ICH Quality Guidelines on pharmaceutical quality-based processes to support client's conformance to Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Storage Practice (GSP) Good Distribution Practice (GDP) processes with reference to and including but not limited to:
- Good Manufacturing Practice Q7
- Good Clinical Practice ICH-E6 GCP
- Pharmaceutical Development Q8
- Quality Risk Management Q9
- Pharmaceutical Quality System Q10