FDA Ready Are You FDA Ready? Code of Ethics Inspection Prep Strategy Services Clients CMOs and Outsourcing Qualifications Partnerships Contact

Are you FDA Ready? To be ready, a company needs to Identify compliance gaps Implement solutions that work Present material to FDA effectively Greg Bobrowicz is an internationally-recognized expert in GMP compliance for biopharmaceuticals, novel dosage forms, and quality systems. In seven years at FDA, he managed the NDA Pre-Approval Inspection (PAI) program for the San Francisco District Office and inspected high-tech companies as a Regional Biotechnology Specialist with the Pacific Regional Biotechnology Team. Since 1998, he has been a critical member of the PAI preparation activities for many successful high-profile products. FDA inspections are inconsistent and unpredictable. Regulatory requirements are a combination of regulation, guidance, and unwritten industry practice. Despite these uncertainties, the consequences of regulatory delays or difficulties can be devastating to a company and to the patients who need the product. FDA inspections focus on results, not good intentions. This regulatory environment demands diligence in all aspects of your products. Everyone has opinions -- you need to know the rules from regulations, guidance documents, and mainstream companies. Audits need to be impartial and thorough. Standards must be industry-standard and fair. Solutions need to be practical, measurable, and achievable. You need to hear what you need to know, not what people want to hear. FDA Ready Consulting provides these services: Inspection Prep Strategy Internal and External Audits Training Compliance Gap Analyses Mock Inspections Expert review of significant problems or deviations Plans and outlines to improve compliance

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