During the development of a new drug, sponsors will show whether the product is safe for early human use and the pharmacologically and clinically relevant activity of the compound that requires further investigation for future commercial growth. If you need any help, the IND consultant will work with or play a role in the Chief Regulatory Officer to prepare and submit to the FDA the regulatory filings for the new investigational drug (IND) and new drug application (ANDA).
When a product is identified as a potential drug candidate for further development and used in limited early-stage clinical research, sponsors need the data and information needed to prove that the product is not exposed to humans. Focus on collecting to unreasonable risk.
Role IND consultants in IND submission
IND consultants are familiar with all aspects of the FDA’s IND submission requirements. IND consulting services include meeting with the FDA for input and agreeing to an IND submission strategy. IND Consulting also ensures that you have the preclinical and manufacturing information needed to submit your IND.
IND Consulting also uses ANDA submissions to provide ANDA consulting services to clients who submit data to the FDA for the possibility of reviewing and approving generic drugs. ANDA’s FDA submission has been “omitted” as it generally does not contain preclinical and clinical (human) data to establish safety and efficacy. Instead, ANDA filing data should demonstrate that generic products are comparable to innovative medicines in quality, performance, and other properties.
As soon as a drug sponsor wants to test the potential of a human candidate, the molecule becomes a legal concern under the US Food, Drugs and Cosmetics Act and is subject to “new drugs.” To the specific requirements of a complete drug regulation system. IND allows new drugs to be shipped across US state borders.
IND considerations:
Through IND consulting, you can set up a pre-IND meeting with the FDA and ship pre-IND meeting packets in bulk. Meeting with consultants and the FDA early in the clinical planning phase can not only save time and money but also reduce dissatisfaction with the new drug regulatory process.
The final IND application requires fully developed information in three areas: animal pharmacology and toxicology research, manufacturing and product specifications and clinical protocols with researchers. Sponsors must wait 30 days after submitting their IND application before starting an investigation that allows an FDA review period.
In the medical industries all companies have to follow IND considerations, to sale their products.
