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Carmen Medina, FDA consultant in her office

charting
your course to
FDA approval

 

 

 

       

 

 

CONTACT US

Call us today for a free consultation on any of the following hot topics:

  • FDA’s Quality by Design (QbD) pilot program for biotech filings
  • How using PAT and PC & C during development will streamline your FDA approval process
  • Pre-approval Inspection (PAI) Readiness Initiative
  • Critical Path Opportunities for generic drug manufacturers
  • Question based review (QbR) and how this reduces your submission timeline
  • Biosimilars and their impact on the regulatory and reimbursement landscapes

Precision Consultants, Inc.
Offices in Boston, MA and Holland, MI

619.944.6137 mobile

carmenmedina@precisionconsultants.com

 
     
 

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