Alira Health

Alira Health

Regulatory: Pharma

Regulatory Strategy and Target Product Profile (TPP)

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Strategic Advice

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:

Our Services:
Due Diligence, Gap analysis, and Roadmaps

As part of our regulatory services, the Alira Health team can:

Our Services:
Scientific Advice

Alira Health can support you for your interactions with the FDA, the EMA or EU National Health Authorities to ask guidance on your proposed development plan, to ensure that the appropriate tests and studies are performed and that no major objections are likely to be raised during the review of the product marketing authorisation application. As part of our regulatory services, the Alira Health team can:

Our Services: Target Product Profile (TPP)

The TPP is essential to guide the entire development program. It is intended to design clinical research strategies, decision making within the organization and improve communication with regulatory authorities. As part of our regulatory services, the Alira Health team can:

Contact us to learn more about how we can support your needs

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