Services

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