Regulatory: Pharma
FDA Applications Preparation, Management, and Submissions
Our services: FDA Applications
As part of our regulatory services in pharma, the Alira Health team can:
- Assist with authoring IND, NDA, BLA for both 505 (b)(1) and 505(b)(2) pathways in addition to ANDA applications
- Serve as the project manager for regulatory submissions, and plan, track, collect, review, and finalize the documents for various modules in an FDA submission as per the eCTD guidelines
- Act as a U.S. agent for FDA Submissions for firms located outside the U.S.
Why choose Alira Health?
As your partner, Alira Health supports your innovation, optimizing product development success every step of the way. Our integrated, collaborative teams provide a lifecycle approach to delivering our services, including:
- Regulatory strategy
- Regulatory intelligence
- Regulatory operations
- Clinical
- Market access