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
