Regulatory & Medical Services
- Prepare & Submit Regulatory dossiers as per regulatory guidelines.
- Liaising & Following up with Regulatory authorities.
- Consultation of Drug & Device Regulations
- Global Clinical Trials - Regulatory Submissions
- Comprehensive gap analysis of regulatory data
- Electronic Common Technical Document (eCTD) services , publishing and regulatory authority submission management
- NCEs, NMEs, devices, generics, biologics, biosimilars and drug-device combination
For more information related to Evolve Life’s regulatory compliance services, feel free to touch base with us.
- Concept Sheet preparation for Abbreviated New Drug Applications (ANDA) submissions
- Protocol writing / Development
- Phase II to IV studies
- Phase I and Patient-based PK studies
- Proof of concept and early phase clinical trials
- Informed consent forms
- Clinical Study Report
- Clinical and non-clinical sections of the Common Technical Document (CTD) including summaries and overviews for EU and US Regulatory Authorities
- Investigator Brochures
- Standard Operating Procedures (SOPs) covering of drug development including
- Reporting of clinical trials