Regulatory Services

Quest life sciences team provides independent regulatory services as an integral component of our services portfolio. Our regulatory affairs team helps the sponsors/client’s navigate complex regulatory requirements throughout the product’s development lifecycle. With in-depth knowledge of local regulatory procedures and effectiveliaisoning with local regulatory agencies ensures high efficiency in the Clinical Trial/BA-BE approval process.

Quest life sciences RA team provides the following :

Our RA team has the complete and comprehensive knowledge of the specific regulatory requirements of international regulatory agencies such as FDA, EMEA, WHO, MCC, TGA etc.

• Support on Indian regulatory environment & requirements.
• 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.

Quest life sciences has successfully completed over 22 audits from Indian & International regulatory agencies, 30+ sponsor audits from Indian and International clients and study submissions have been made to more than 8 countries.

Team QLS executes all the studies in strict compliance with regulatory and ICH GCP requirements.