IND & ANDA Filings and Consulting Services

IND filings & ANDA Filing - Consultation - IRISYS

IRISYS will work with, or function as, your Head of Regulatory to prepare and submit Investigational New Drug (IND) and Abbreviated New Drug Application (ANDA) regulatory filings to the FDA. We personalize our services for each client based upon your products and internal capabilities.

IRISYS has expertise with all aspects of FDA IND filing requirements. Our IND consulting services include meeting with the FDA to gain input and concurrence with IND filing strategies, a critical step for reducing time and costs. We will also ensure that you have the required preclinical data and manufacturing information for your IND filing.

IRISYS also provides ANDA consulting services for clients using an ANDA filing to submit data to FDA for the review and potential approval of a generic drug product. FDA ANDA filings are “abbreviated” because they generally do not include preclinical and clinical (human) data to establish safety and effectiveness. Instead, data in ANDA filings must demonstrate that the generic product is comparable to an innovator drug product in quality, performance, and other characteristics.

IRISYS’ ANDA consulting team will work with you to establish strategies and prepare your FDA ANDA filings.

CMC (Chemistry, Manufacturing and Controls) section of IND filing 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, contact us below: