Submission of dossiers to USFDA, EU and ROW authorities for approvals and undertake all the follow-on activities such as such as addressing deficiencies, questions & explanation during registration phase in the territory.

VivaTest’sin-house team of regulatory experts facilitates meeting challenging timelines and our processes are designed to provide cost effective study management solutions towards regulatory authorizations.

Key Services

  • Pre-Formulation studies
  • Development of the core formulations with different Dosage forms like Tablets / Capsules / Ointment / Cream / Gel / Syrup / Suspension / MDI / DPI / Nebulizers / etc.
  • Analytical Method Development and Validation
  • API and Impurity Characterization
  • Stability Studies
  • Manufacturing Process Validation
  • Validation Batches/ Batches for Clinical Trials
  • Technology Transfer
  • QbD and DOE application as per client requirements
  • Documentation for all our Formulations for CTD/ ACTD/ eCTD/ CEP
  • Dossier Preparation/ Submission
  • Drug Master File for API, Excipients and Primary Packaging material in India and Overseas