Our Regulatory professionals are very involved from the first interaction with federal authorities to the final submission and after. Building on the first feedback from the regulatory authorities/FDA our team will assess the right pathway to successful conduct and submission of the clinical trial while understanding the critical requirements of the FDA based on their laid guidance.
Our key Regulatory Services include:
- Interact with the Regulatory agency during Initial Pre-study as well as Final submission.
- Prepare Documents/Data for submission
- Prepare responses after the trial submission based on queries
- Advise during the whole clinical trial process based on data analysis
- GAP Analysis
- Regulatory Support to the site
