What is IND / NDA Filing Assistance?
The Investigational New Drug Application or the IND is the launching point for clinical investigations in the US. It is a necessary step along the path of launching a new drug in the market. The primary purpose of an initial IND submission is to ensure the safety and rights of the participants in the clinical trial.
The New Drug Application or the NDA is a formal request made by the Sponsor to market the new drug in the US market. NDAs are usually regulated by the FDA’s Centre for Drug Evaluation and Research (CDER). The goal is to provide enough evidence and support for the safety and effectiveness of a drug and how that the benefits outweigh the risks.
Who needs IND / NDA Filing Assistance?
Any Sponsor who wants to market a drug in the US market and distribute it across state lines. You may wish to ship the investigational drug for clinical trials in multiple states. This requires an exemption from the FDA and you can achieve that with the help of an IND filing.
The NDA application is required by drug sponsors who want the FDA to approve a new pharmaceutical drug for sale and marketing in the US.
What is the process of IND Filing?
Filing for an IND requires you to complete filling 3 sets of forms.
- The first form – Detailing the study – FDA Form 1571
- The second form – Providing information about the investigator and Study Site – FDA Form 1572
- The third form – Certifying that the study is registered in the national database of clinical trials – FDA Form 3674
- Once the forms have been filled, it will go in for a review to check if it is complete and can be accepted.
How can Perfect Pharmaceuticals Consultants help?
Perfect Pharmaceuticals Consultants has an experience of over 20 years in the field of regulatory filings. You need to understand the various types of drug applications and the need for each application. This can get tricky when done on your own. Contact us today to make the most of our services and how we can assist you with your IND/NDA filing assistance.