Overview
The Drug and Device Regulatory Assistance Program offers comprehensive support to researchers navigating the complex landscape of FDA regulations. Our experienced team provides tailored guidance and assistance throughout the research process, from early-stage development to clinical trials and considerations for commercialization.
Support Offered:
- Regulatory Consultations: One-on-one consultations with experienced regulatory experts to help you understand FDA requirements and identify the appropriate regulatory pathway for your research.
- Protocol Review: Assistance reviewing research protocols to ensure compliance with FDA guidelines and IRB requirements.
- IRB Submission Support: Guidance and support in addressing FDA requirements in preparation of IRB submission and addressing any questions or concerns raised by the IRB.
- FDA Submission Preparation: Assistance in preparing and submitting regulatory documents to the FDA, including pre-submission and meeting requests, INDs, and IDEs.
- Regulatory Compliance: Ongoing support to ensure compliance with FDA regulations throughout the research process.
By utilizing our Drug and Device Regulatory Assistance Program, you can navigate the complexities of FDA regulations with confidence and increase the likelihood of successful research outcomes.
