Regulatory Services
Patient Profiles & Data Cleaning, Reporting, Regulatory Services and QA – Our Service Portfolio
Regulatory Services & QA are integral components of the service portfolio at Lotus Labs. The dedicated team for regulatory services and audit compliance at Lotus Labs is backed by in-depth knowledge of local regulatory procedures and effective liaison with various regulatory agencies, ensuring efficiency in the Clinical Trial approval process.
While Regulatory Services in Lotus Labs has successfully completed more than 117 inspections from Indian & International regulatory agencies, study submissions have been made to more than 45 countries. Lotus Labs has also been approved for submission of studies to MOH Israel, National Medicines & Poisons Board, Republic of Sudan, FDA, EMA, ANSM, ANVISA, WHO, NPRA and DCGI.
The range of regulatory services offered include
- Formulation of regulatory strategies
- Compilation of the clinical trial application
- Submission and follow-up of the application
- Response to regulatory agency queries
- Procurement of drug import licenses
- Procurement of NOC for the conduct of the study
- Procurement of NOC for the export of biological samples
- Tracking of applications and approvals
- Safety Reporting
- Submission of Clinical Safety Report (CSR)
- Renewal of Import License
15 Investigator sites that Lotus has worked with for patient based studies in India, have been inspected by the USFDA.