Our Regulatory professionals are actively engaged from the initial interaction with federal authorities through to the final submission and beyond. Leveraging initial feedback from regulatory authorities, including the FDA, our team assesses the optimal pathway for the successful conduct and submission of clinical trials, ensuring adherence to the FDA’s critical requirements and guidelines.
Our key Regulatory Services include:
- Regulatory Agency Interaction: Engaging with regulatory agencies during both initial pre-study phases and final submission to ensure seamless communication and compliance.
- Document and Data Preparation: Preparing comprehensive and accurate documents and data packages for regulatory submission, adhering to all relevant guidelines and standards.
- Query Response Preparation: Crafting detailed and precise responses to regulatory queries post-submission, ensuring timely and satisfactory resolutions.
- Clinical Trial Advisory: Providing expert advice throughout the clinical trial process based on ongoing data analysis, enhancing trial design and execution.
- GAP Analysis: Conducting thorough GAP analyses to identify and address any discrepancies or deficiencies in trial protocols or documentation.
- Site Regulatory Support: Offering robust regulatory support to trial sites, ensuring adherence to regulatory requirements and facilitating smooth trial operations.
