Our pharmaceutical consulting group has expert ANDA Consultants, NDA Consultants and IND Consultants to provide the best support for our clients. Biotech Research Group’s FDA Consultants has in-depth knowledge on how to prepare all FDA drug submissions including:

  • ANDA application (Abbreviated New Drug Application)
  • NDA application 505 (b)(2) (New Drug Application)
  • INDapplication (Investigational New Drug)
  • DMF application (Drug Master File)

Unlike other pharmaceutical consulting firms, our certified regulatory professionals have well over 50 years of combined experience building strong relationships with FDA agents. Let our knowledgeable staff provide you with full-service for your submission or serve as a partner to guide you through the drugs FDA pathway. Most pharmaceutical research companies will advise you that the FDA requires pre-clinical and clinical data providing the safety and efficacy of the drug. The FDA will inquire about the manufacturing processes as well. Each milestone in the process is significant and if there is insufficient preparation, the drug development strategy will be flawed. Our FDA drug consultants will ensure at the end of each FDA meeting, the client is clear with what is needed to move forward. Along with a well-developed strategy for your drug, Biotech Research Group offers the following services to our pharmaceutical clients:

  • FDA briefing package
  • Pre-IND meeting
  • FDA communications and meetings for all phases
  • Pre-NDA meeting
  • Orphan drug designation
  • Clinical trials coordination
  • Literature reviews
  • Scientific research
  • 513(g) Request for Information
  • ANDA suitability petitions
  • Technical documents review
  • FDA regulations interpretation

Whether it is an IND FDA application or an ANDA, many FDA submissions are not approved initially. Biotech Research Group has the drug expertise you need to increase your chances of initial approval, saving you both time and resources

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