Regulatory Strategy and
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
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).
The EU Pharmaceutical Package: Regulatory Protection Changes
Our regulatory experts present a more detailed analysis of the proposed changes introduced to Regulatory Data Protection (RDP).
Medical Device Regulation: A Checklist for Preparation
This checklist can provide you with insight into where you stand in regards to MDR preparation and what you still need to address.
The EU Pharmaceutical Package: Introduction to Changes
Alira Health’s Regulatory experts explore how the proposed package will disrupt the European regulatory landscape and what it means for companies.
Access and reimbursement pathways for digital health solutions and IVD devices
Digital therapeutics (DTx) are innovative solutions that use meaningful data to provide evidence-based decisions for the prevention, treatment, and management of diseases. Particular(...)
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.