FDA Regulatory Consulting
FDA Consultants Ease Regulatory & Process Validation Headaches
It makes sense: a consultant that’s a former FDA inspector understands regulatory issues from the inside out, unlike consultants simply trained in process validation & compliance. One is a hands-on “insider,” while the other relies on “textbook” training. Make sure your FDA consultant knows your compliance needs from the inside…
Smart FDA Consultants Teams include both industry & regulatory agency experts. This balanced approach gives you Effective AND Efficient approaches to your FDA regulatory and compliance needs.
FDA inspections can be stress-free when your consultant knows exactly where the problem areas are that need to be addressed, and what the FDA hot buttons are for those areas. For example, Smart Consultants created a proprietary mechanism that can initiate anonymous FDA inquiries on your most delicate compliance issues ahead of time. This helps you reduce your exposure to addressing potentially delicate problems and making necessary operational changes BEFORE they come up on your actual FDA inspection.
Smart FDA Consultant Teams also give you rapid incorporation of CMC (Chemistry Manufacturing Control) and related materials for eCTD (electronic Common Technical Documents) submissions, to help make these potentially cumbersome functions Lean and efficient.
Smart Consultants ex-FDA experts bring you unique, priceless insights into the FDA process to give you a competitive advantage and a “fresh eyes” approach to an area which ultimately requires tremendous flexibility to be effective. Find out how much more stress-free Smart FDA Consultants can make your regulatory and compliance issues… Ask the 7 Questions: