Regulatory
Regulatory
globeELIXIR 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 with various regulatory agencies that ensures high efficiency in the Clinical Trial approval process.
globeELIXIR 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
- Obtaining registration documents in the interest of clients
- Continuous follow-up post submission with regulatory authorities
- Renewal of Import license and Safety reporting
Regulatory offerings in globeELIXIR have successfully completed multiple audits from Indian & International regulatory agencies, and audits from Indian and International clients and study submissions have been made to multiple countries.