The FDA Drug Approval Process.

We work to get and maintain FDA approvals.

Our experts have worked over 35 years on:

  • New Drugs
  • Generic Drugs
  • DESI Drugs
  • OTC Drugs

We have succeeded in every drug therapeutic category because we know the FDA approval process 'inside out'.

We know what is needed because we have compiled successful documentation in all these areas:

  • GMP/GCP/GLP Compliance
  • SOP Writing 
  • Toxicology
  • Formulation
  • Pre-Ind Meetings
  • Validation
  • Electronic Submissions
  • FDA Drug Recall
  • FDA Consultant-Audit Inspections and Operations 
  • IND
  • NDA
  • ANDA
  • BLA

FDA approvals are difficult to obtain, difficult to maintain and traumatic to lose. You need an FDA expert who knows the importance of fast and effective action when your product has to be managed through the FDA drug approval process. Contact us today to discover how we can help you.