About Us

About Us

WE ARE THE TRUSTED EXPERTS

Our team of consultants brings decades of product development and regulatory consulting experience for pharmaceuticals, biologics and medical devices.  We are dedicated to working closely with you through every stage of your product’s development process and help you bring your product to market in the most efficient manner.

 

WE CAN:

  • Develop pragmatic approaches to regulatory challenges
  • Negotiate with the FDA and EU
  • Write, manage and review all modules of the CTD, IB, annual reports, and meeting packages
  • Prepare Orphan Drug Applications
  • Develop concise and thorough regulatory strategies
  • Strategically determine product placement
  • Utilize expedited regulatory pathways
  • Preform Due Diligence
  • Resolve complex pharmacology/toxicology, clinical or CMC issues
  • Serve as your US Agent
  • Prepare Integrated Development Plans
  • Publish your eCTD submission

OUR EXPERT TEAM