Consultancy and Contract Manufacturing – Assisting small and large scale pharmaceutical companies in the following areas:
- Formulation development & Manufacturing
- Quality assurance/Quality control
- Raw Material testing
- Finished product testing
- Stability testing
Marketing, Exporting and Distribution of Finished products – Making Vinkem’s and other companies’ drug products affordable for the patients/consumers.
Regulatory Affairs & Bioanalytical – Assisting small and large scale pharmaceutical companies in the following areas:
- eCTD/CTD version of submissions for Health Canada, USFDA, and EMA (Europe).
- Bioavailability/Bioequivalence studies (BA/BE) for NDA and ANDA submissions.
- Predict/Simulate in-vitro concentrations based on in-vivo (simulated or actual) data/results.
- In-depth PK and PK/PD modeling
- Study design and Sample size estimation for clinical trials.
- Pharmacokinetic Data Analysis Plan and Clinical Study Report.
- Statistical analyses using Phoenix WinNonlin, Excel, and/or SAS