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Dossier Preparation and Submission

Program Assistance for NDA, BLA, MAA, and IND/CTA

Our regulatory services are tailored to meet the diverse needs of pharmaceutical and healthcare companies navigating the intricate landscape of regulatory compliance. For FDA submissions, we specialize in the preparation, management, publishing, and submission of applications including IND, NDA, BLA, supplemental NDA/BLA, and ANDA applications. Our expertise includes EMA and EU Member States National Health Authorities, where we facilitate the preparation, management, publishing, and submission of applications including Marketing Authorization Applications, Clinical Trials Applications, as well as variations and renewals.

How We Help Clients

FDA Application Preparation, Management, Publishing and Submission

As part of our regulatory services, the Alira Health team can:

Prepare and submit IND, NDA, BLA, supplemental 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 required as per the eCTD guidelines.
Act as a U.S. agent for FDA Submissions for companies located outside the U.S.

EMA and EU Member States National Health Authorities Applications Preparation, Management, Publishing and Submission

As part of our regulatory services, the Alira Health team can liaise with health authorities and also prepare and submit:

Marketing Authorization Application (Centralized, Decentralized, National and Mutual Recognition Procedures)
Serve as the project manager for regulatory submissions, and plan, track, collect, review, and finalize the documents required as per the eCTD guidelines
Clinical Trials Application (CTAs)
Variations (Type IA, IB and II) and renewals

Why Choose Us for Your Dossier Preparation and Submission?

Expertise: Benefit from our team's deep knowledge and extensive experience in dossier preparation and submission for FDA and EMA/EU Member States, ensuring compliance and efficiency throughout the process.
Comprehensive Support: We offer end-to-end support, from initial planning and document collection to final submission, serving as your dedicated project manager to streamline the entire regulatory journey.
Global Reach: Whether you're based in the U.S. or abroad, leverage our global presence and U.S. agent services to seamlessly navigate regulatory requirements and expand your market reach.