FDA - Expertise & Support
Current status assessment
We assist you to secure your compliance with our Process & Regulatory Affairs Experts
The FDA (Food and Drug Administration), the health authority responsible for approving new drugs and new manufacturing sites, has a process for conducting pre-approval inspection (PAI) investigations like no other agency in its methodology. They have not delegated this responsibility to other agencies through mutual recognition programs.
They carry out numerous inspections in the workshop, observe the technicians performing their work, explore the quality systems to ensure that the quality systems are effective in guaranteeing product quality and look for any inconsistencies in the data and reports.
Their inspection is motivated by the examination of the quality systems, their processes, a perfect knowledge of the product, its process and the demonstration of its robustness.
- Assessment against the FDA benchmark. Approximately 5 days on site. Deliverables: Deviations-Rating and Action Plan
- Support for the implementation of the action plan to achieve compliance
- Support for PAI and FDA inspections
- Implementation of missions by experts with extensive experience and knowledge of the FDA (CBER & CDER)
- Knowledge and experience of FDA operations and culture
- Already existing relationships
Take advantage of experienced experts and benefit from their experience