Our Services:
Strategic Advice
Alira Health can help you developing a plan of action designed to achieve a specific regulatory goal, such as to obtain the approval of a new drug, biologic or combination product. A solid regulatory strategy and execution can maximize the opportunity to achieve your objectives and provide a competitive advantage. Our strategies are designed to help you balance risks, increase speed and decrease costs associated with your projects and business objectives.
As part of our regulatory services, the Alira Health team can: - Analyze product attributes that could have a regulatory impact.
- Propose a global development plan in adequation with your company’s objectives
- Document the strategy by outlining different development scenarios.
- Verify the viability of your proposed strategy.
- Provide recommendations on your product positioning/classification.
- Conduct regulatory intelligence.
- Monitor the regulatory environment and internal/external drivers for change.
- Provide strategic consultancy from our multidisciplinary team to address specific challenges