IND & ANDA Filings

IND filings & ANDA Filing - Consultation - IRISYS

IRISYS will work with, or function as, your Head of Regulatory to prepare and submit regulatory filings to the FDA. We personalize our services for each client based upon your products and internal capabilities.

CMC (Chemistry, Manufacturing and Controls) section of IND preparation

IRISYS will be responsible for:

  • Data generation
  • Reports
  • Preparation of the CMC section for submission

IND & ANDA (Abbreviated New Drug Application) preparation and submission

IRISYS will be responsible for:

  • Preparation of your IND or ANDA application in eCTD format
  • Electronic submission of the IND or ANDA to the FDA

For more information about our IND & ANDA Filing services, fill out the contact form below: