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.
Regulatory Strategy for Registering Rare Disease Products in the EU
In this webinar we will focus on how to benefit, today and in the future, from the orphan drug program and build a regulatory strategy for successful rare disease product registration(...)
White Paper: New European Health Technology Assessment Regulation
In this white paper, we provide an overview of this new regulation, including key points of the new European Health Technology Assessment Regulation, its methodology, and its timelines.
How to leverage registry-based studies to generate high-quality Real-World Evidence
The use of Real-World Evidence (RWE) in regulatory decision making will support the development and application of better medicines.
How to successfully use the EMA IRIS portal to ensure timely submissions
Submitting your scientific advice (SA), orphan drug designation (ODD) or Innovation Task Force (ITF) consultation to the EMA? Avoid delays with our submission recommendations.
Webinar Replay: What You Should Know About MDR Best Practices, Including PMCF
Discover the major changes introduced by the MDR, including the post-market requirements, and especially the Post-Market Clinical Follow-up (PMCF).
DTx France 2022
We are pleased to announce that we will be joining as speakers and exhibitors at DTx France 2022. This hybrid event will focus on the latest DTx trends, regulatory framework, market(...)
DIA 2022 Global Annual Meeting
We are pleased to announce that we will be joining DIA 2022 Global Annual Meeting as exhibitors and delegates.