Regulatory Strategy and Due Diligence
Our services: strategy and due diligence.
As part of our regulatory services in pharma, the Alira Health team can:
- Assist with target product profile development
- Support the product development plan
- Deliver road map design: an analysis and presentation of the number of pre-clinical and clinical studies that may be required for the marketing application
- Provide strategic consulting from our multidisciplinary team to address specific challenges
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
Explore our related publications.
DIA 2022 Global Annual Meeting
We are pleased to announce that we will be joining DIA 2022 Global Annual Meeting as exhibitors and delegates.
U.S. and European Regulatory Strategies for Asian MedTech Startups
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Cheat Sheet: MDCG Guidance on Medical Device Classification
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Alira Health Strengthens Clinical Operations with the Acquisition of Sourcia
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The FDA’s Project Orbis Can Speed up the Delivery of Your New Oncology Drug to Global Markets
Are you developing an oncology drug? Project Orbis, a program coordinated by the U.S. Food and Drug Administration (FDA), allows you to register your product in several countries with(...)
European Commission’s New Regulation Amending IVDR Transitional Provisions: What You Need to Know
The European Commission (EC) has published an amendment of the IVDR, delaying the transitional period for some IVDs. However, the IVDR Date of Application remains the same, so Alira(...)
Webinar Recap: Risk Management & Regulatory Submissions
Download Alira Health's Senior Vice President, Regulatory Affairs, Mary McNamara-Cullinane's webinar presentation, How to Implement Risk Management into Regulatory Submissions Using(...)