With in-depth knowledge of local regulatory procedures and effective liaisoning with local regulatory agencies Vayam ensures high efficiency in the Clinical Trial/BA-BE approval process.
Services offered are :
- Executing regulatory submissions (Protocols, Ethics committee documents & compiling dossiers).
- Preparation & submission of complete range of regulatory documents for obtaining:
- Approval to conduct BA-BE studies/clinical trial in India.
- Approval to import Test Drug.
- Continuous follow-up post submission with regulatory authorities.
- Renewal of Import license.
English
Dutch
French
German
Spanish