Precision Consultants Inc. brings you a cadre of former FDA investigators, FDA reviewers and FDA compliance officers who are not afraid to assertively drive your marketing strategies and defend your company with proven regulatory tactics. We offer the most current analysis of political, regulatory and compliance developments within FDA-regulated industries.
PCI recognizes that ours is an industry where opportunities abound and success must be expertly charted. Let us compress your concept-to-commerce timeline with creative FDA regulatory and compliance solutions. Who we are . . .
OUR PHILOSOPHY:
The price of knowledge is not as high
as the price of ignorance.
Our industry affects the lives of every man, woman and child on this planet. This is why we feel such passion about our work. Precision Consultants, Inc. unites the exacting science of drug development with the art of regulatory science to give your company an edge in one of today's fastest growing industries.
This is an especially exciting and challenging time for FDA-regulated industries. More than ever, it is essential to evolve with the most innovative, efficient and precise approaches in order to contend with global competition, heightened consumer demands, skyrocketing R & D costs, FDA User Fees and an increased enforcement environment.
Our consultants believe that for a company to be evolutionary it must be willing to look for new approaches and practices that are appropriate for them. Firms must commit to retaining the best aspects of what's already in place, while adapting new ideas to their current methods and philosophies. No one knows your company better than you.
Let us help you leverage the FDA's latest regulatory initiatives, such as FDA’s Quality by Design (QbD) pilot program for biotech filings, Critical Path, PAT, QbR and Risk Mapping, in an effort to get your quality products to market faster. We believe there has never been a better time in the FDA’s history to bring new products to market.
LATEST PUBLICATIONS:
“How to Avoid Becoming a Biotech Zombie” A three part series by Carmen Medina, published by BioPharm International - February 2008
“Biosimilars and the Changing Environment of Regulation and Reimbursement“ Article by Carmen Medina, published BioPharm International, October 2007