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
- Market access
Look for our clinical development experts Chris Rao and Kenny Carberry as delegates onsite at MassMedic Regulatory Roundup.
Impact of the New EU HTA Regulation on Access to Innovative Medicines in Europe
In this interview, Alira Health Partner Chus Castillo gives updates on HTA Regulation, related challenges, and potential effect on access to innovative medicines.
The EU Pharmaceutical Package: Impact on Orphan Medicinal Products
This article reviews the proposed changes in the EU Pharma Package for data protection related to orphan medicinal products (OMPs).
The EU Pharmaceutical Package: Regulatory Protection Changes
Our regulatory experts present a more detailed analysis of the proposed changes introduced to Regulatory Data Protection (RDP).
Medical Device Regulation: A Checklist for Preparation
This checklist can provide you with insight into where you stand in regards to MDR preparation and what you still need to address.
The EU Pharmaceutical Package: Introduction to Changes
Alira Health’s Regulatory experts explore how the proposed package will disrupt the European regulatory landscape and what it means for companies.
Access and reimbursement pathways for digital health solutions and IVD devices
Digital therapeutics (DTx) are innovative solutions that use meaningful data to provide evidence-based decisions for the prevention, treatment, and management of diseases. Particular(...)