Stage Development

API Technology Development – Early Stage

Your assigned Development Team will partner with you in creating a strategy tailored to each compound.

This will include:

  • Master Plan for Development – Short term strategy and Long term strategy
  • Process development – Synthetic chemistry and Analytical procedures required
  • Pre-clinical Trials and Tox Studies – initiate cGMP manufacturing
  • IND filing – Specification development, Product characterization, Analytical method development/validation
  • Scale-up manufacturing (cGMP) and ICH stability
  • Clinical Trials (Phase I & II) – manufacturing and regulatory support

API Technology Development – Late Stage

The Development Team will work with you to achieve your economic goals and to satisfy regulatory requirements.

This will include:

  • Clinical Trials (Phase III) – establish final scale for product launch
  • Commercial Scale-up and Process Validation – finalize manufacturing process for product launch
  • NDA filing – CMC data and Drug Master File support
  • Product Launch
  • Niche Commercial Manufacturing