The independent team for regulatory services helps you navigate complex regulatory requirements throughout your product’s development lifecycle. We have an in-depth knowledge of local regulatory procedures and dedicated and effective liaisoning with various regulatory agencies that ensures high efficiency in the Clinical Trial approval process.
In order to receive regulatory approval, you invest big money and years in drug development. Never let the intricacies of filing across multiple countries delay your launch. Banking on Spoorthy solutions’’ integrated cross-functional expertise and flexible sourcing options, our clients
Spoorthy solutions’ services include but not limited to:
- Offer support on Indian regulatory environment & requirements
- Compiling dossiers
- Executing regulatory submissions
- Preparation & submission of complete range of regulatory documents for obtaining:
- Approval to conduct clinical trial in India
- Approval to import Test Drug
- Approval to export Biological Samples
- Liaisoning and Obtaining registration documents in the interest of clients
- Continuous follow-up post submission with regulatory authorities
- Renewal of Import license
- Safety reporting
- BENOC- T-license filling
- NSWS filling
- SAE reporting on sugam portal
