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.
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We are pleased to announce that we are joining Regulatory Roundup as sponsors and speakers. This unique event is hosted by MassMEDIC, the largest regional medtech association in the United States.
Medical Device Regulation in 2023: A Window of Opportunity
We spoke with our team of regulatory experts about the recent news regarding the MDR and the opportunity it presents to device manufacturers in 2023.
Regulatory Strategy for Registering Rare Disease Products in the EU: What You Need to Know
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2022 Recap: Your Favorite Alira Health Publications
In 2022, the Alira Health team of scientists, strategists, economists, clinicians, and biostatisticians shared actionable insights, industry thought leadership, and leading-edge guidance(...)
Webinar Replay: Partnering with Patients to Streamline Trial Operations: Protocol to Regulatory Submission in 60 days
Learn how patients and patient advocacy organizations can be directly enabled as powerful partners to facilitate all stages of DCT deployment, from protocol design, recruitment, engagement(...)