FD-AID Consultants include both industry & regulatory agency experts. This combined experience gives you an effective and efficient approach to your FDA regulatory and compliance needs. When you have had or anticipate FDA inspectons or correspondence, you want assurance that your interaction works in favor of your company.
It makes sense – a consultant who is a former FDA inspector would understand regulatory issues from the inside out, unlike consultants simply trained in process validation & compliance. A pharmaceutical industry expert is aware of the intricate needs of the business while recognizing the need to remain compliant. FD-AID provides the synergy of both to allow the best outcome for your company.
FDA inspections do not need to be so stressful when your consultant understands the problem from an FDA perspective as well as a business perspective. FD-AID has the seasoned experience to aggressively address regulatory concerns and provide sustainable corrective actions. FD-AID can also communicate with FDA as an anonymous party to gain greater insight on regulatory concerns. .
FD-AID’s Team incorporates A/NDA CMC (Chemistry Manufacturing and Controls) and related materials for eCTD (electronic Common Technical Documents) submissions to help make potentially cumbersome functions efficient.
Find out how FD-AID pharmaceutical consulting can make regulatory and compliance issues a much less stressful experience.