Regulatory: Pharma

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
  • Clinical
  • Market access

Related news

Publications January 19, 2023
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.
Medical Devices MedTech Regulatory
Publications January 11, 2023
Regulatory Strategy for Registering Rare Disease Products in the EU: What You Need to Know
Given that the regulation is likely to change considerably, drug developers may need to revisit their development strategy. In the meantime, building a strategy around these evergreen(...)
EU Rare Disease Regulatory
Publications December 21, 2022
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(...)
Clinical Digital Health Market Access MedTech Pharma Regulatory
Multimedia December 17, 2022
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(...)
Clinical Trials Patient Centric Regulatory
Publications November 22, 2022
External Control Arms: The Way to Go?
The growing implementation of Single Arm Trials (SATs) with External Control Arms (ECAs) has been the subject of heated debate across Europe.
Clinical Trials Regulatory
Events October 7, 2022
Debate Sobre los IPT en Oncología
We are pleased to announce our next event, “Debate Sobre los IPT en Oncología,” focusing on price and reimbursement (P&R) of vital oncology and oncohematology therapies.
Market Access Product Development Regulatory
Events October 6, 2022
The MedTech Conference 2022
We are pleased to share that we will be joining the MedTech Conference 2022 as sponsors and speakers! This year’s edition will have more than 100 sessions focusing on today’s hot topics.
M&A MedTech Regulatory
Welcome to Alira Health. This site is best viewed in Chrome, Microsoft Edge, or Firefox.