Together, we can prepare your team for FDA and Notified Body inspections. Audits and/or gap analyses to
identify areas of concern and implementation of S4 (Simple, Systematic, Sustainable, and Scaleable) solutions are essential.
But confident, knowledgeable personnel are just as important. When interacting with any regulatory agency, it is not only
what you know and what you do to ensure compliance, but also how effectively you communicate the information.
Our “Simulated FDA-Audits” (SIMFAs) will help your Subject Matter Experts (SMEs) develop the skills and confidence they need to interact like the professionals they are. When a regulatory inspector/investigator is on-site, our experienced consultants can provide invaluable, real-time support regarding back-room document review and preparation, SME rehearsals before speaking with the FDA or other investigators, and all levels of inspection support.
When direct interaction with the FDA or other inspectors/investigators is required, our highly experienced Executive Associates can act as direct on-site liaisons on your behalf, or support your team in whatever capacity management deems is appropriate for the situation.
After the inspection, under-or over-committing to timelines or milestones beyond the client’s resources are common hazards. Our team will work with you in preparing responses to FDA 483s (and Warning Letters, if it happens) or ISO non-conformances that address the issuing agency’s concerns, while ensuring the commitments made are effective, responsive, workable - and sustainable.
FDA INSPECTION READINESS
COACHING AND PREPARATION
AGENCY LIAISON (ON BEHALF OF CLIENT)
It's essential. It's unavoidable. And let's face it - it can be downright nerve-wracking.
It's a regulatory inspection. And sooner or later, it's coming your way. But you will be ready.