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FDA consulting services to
the drug, biologic and medical device industries

Precision Consultants, Inc. is an FDA consulting firm that unites the exacting science of drug development with the art of regulatory science to give your company the competitive edge.

As seasoned FDA consultants, we offer precise interpretation of FDA regulations and work closely with the USFDA to insure the public's safety, product integrity and to protect your bottom line.

Our FDA consulting services cover a wide range of regulatory, compliance and quality assurance expertise related to cGMPs, cGCPs and QSR. Our team of former FDA officials can help you fast track development and commercialization, while leveraging critical initiatives such as FDA's Quality by Design (QbD) pilot program for biotech filings, Critical Path, PAT, QbR and Risk Management. (View a brief video about our customized FDA services - 2:33 min.)

Call Precision Consultants today and speak with one of our experienced former FDA officials to learn more about how our FDA consulting company can help you gain FDA approval for your product.

Llame a Precision Consultants y hable con uno de nuestros exoficiales de la FDA para aprender más sobre cómo nuestra compañía que se especializa en casos de la FDA puede ayudarle a ganar la aprobación de la FDA para su producto.

Appelez "Precision Consultants" et demandez à parler à un de nos collaborateurs munis d'une expérience acquise depuis de nombreuses années dans l'homologation de divers produits. Il ou elle sera vous guider dans les démarches nécessaires pour obtenir l'accord officiel et indispensable au lancement de vos produits.


Learn more about Carmen Medina's textbook: Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics.

See Carmen Medina's latest publications at BioPharm International.

FDA NEWSLETTER

FDA INSIGHTS

Priceless wisdom from former FDA officials

510(k) Presents a Challenge to Medical Device Manufacturers
Carmen Medina, MPH, Ph.D. (c)

The Days of Aggressive FDA Enforcement Are Back!
Carmen Medina, MPH, Ph.D. (c)

Truth in Advertising

FDA Fights Battle on Two Critical Fronts
Carmen Medina, MPH, Ph.D. (c)

FDA Passes New Legislation

Discover how
QbR expedites
your regulatory
submission process

 

Explore how generic
drug manufacturers can capitalize on critical path
opportunities

 

Discuss how QbD
pays off during
development, PAI,
commercialization
and tech transfer

 

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