Events
Regulatory Roundup
Look for our clinical development experts Chris Rao and Kenny Carberry as delegates onsite at MassMedic Regulatory Roundup.
Research and Clinical Development Solutions
Regulatory Services
From Regulatory Strategy to Submission and Beyond, Alira Health Supports Global Product Development
Regulatory approval moves your product from innovation to market. Defining a regulatory strategy that maps your journey through the approval process is critical but understanding the regulatory requirements that govern your market takes a broad knowledge base and a wide range of expertise.
Alira Health is a full-service regulatory partner with decades of global regulatory experience, thanks to a cross- functional team spread between the US and EU, and a large network of consultants and KOLs to ensure tailored strategies, efficient submissions, and successful approvals.
Pharmaceuticals (Drugs and Biologics)
Explore
- Dossier Preparation and Submission (NDA/BLA/MAA, IND/CTA)
- Health Authority Interactions (FDA/EMA/National Health Authorities)
- Accelerated Regulatory Pathways (BTD, PRIME, Fast-Track…)
- Special procedures (Orphan, Pediatric, Expanded/Early Access Program)
- Assistance with Administrative Procedures (US Agent, SME)
- Participation in European Funding Programs for Innovative Products (i.e., Horizon Europe)
- Regulatory Strategy and Target Product Profile (TPP)
Why Choose Alira Health for Regulatory?
The Alira Health regulatory team has decades of global regulatory experience and can deliver tailored strategies, efficient submissions, and successful approvals for devices, biotech, digital health, and diagnostics. Our wide-ranging expertise across therapeutic areas include:- Leadership with over 25 years of experience in regulatory affairs
- Regulatory team with strategic and analytical mindset
- Working/leading with multidisciplinary expertise in multicultural environment
- Proven expertise from early drug development (pre-IND/scientific advice) to MAA/NDA/BLA filing
Publications
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.
Publications
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).