Investigational New Drug Consulting Service – Making Your Drug Development Easy 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 forfurther development and used in limited early-stage clinical research, sponsorsneed the data and information needed to prove that the product is not exposedto 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 consultingservices include meeting with the FDA for input and agreeing to an INDsubmission strategy. INDConsulting also ensures that you have the preclinical and manufacturinginformation 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