Call: 732-640-8338

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
research

Research & Development

  • Formulation development
  • Analytical Method Development
  • Analytical Method Validation
  • Pilot scale-up
  • Process validation
consultancy

Consultancy Services

  • Formulation development & Manufacturing
  • Quality assurance/Quality control
  • Raw Material testing
  • Finished product testing
  • Stability testing
manufact

Contract Manufacturing/Marketing

  • Adequate Capacity
  • Cost Effective Production
  • Special Orders
  • Ready to ship Inventory
  • On-time Delivery & Logistics
bioanalytical

Regulatory Affairs &
Bioanalytical Services

  • eCTD/CTD filing
  • Clinical Trial Support (PK, BA-BE, DDI, DE, SS)
  • IVIVC
  • Clinical Trial Protocol Design/Study report (FDA, EU, TPD, ICH, Client specific)
  • Bioanalytical Method Development