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Regulatory Strategy and Target Product Profile

Gain Strategic and Scientific Advice, Due Diligence, Gap Analysis and Road Maps

We provide comprehensive regulatory services to empower clients in achieving their goals efficiently. Our strategic advice focuses on developing tailored plans to navigate regulatory challenges. We conduct due diligence, gap analysis, and roadmaps to ensure seamless product development, while offering scientific advice and assisting in target product profile (TPP) development for informed decision-making.

How We Help Clients

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

Strategic Advice

We can help you develop 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

Due Diligence, Gap analysis, and Roadmaps

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

Support the product development plan
Deliver gap analysis: identify the gaps and propose solutions for the issues identified considering the current state of the product and the desired end goal (i.e., First in Human Clinical Trial, Marketing Authorisation)
Deliver executable roadmaps: analysis and presentation of the requirements (pre-clinical, clinical studies and regulatory) needed for the company goal (i.e., marketing authorisation)
Perform a due diligence in collaboration with other departments (i.e., Marketing, Clinical, Market Access) by assessing and identifying potential regulatory red flags for an asset
Provide strategic consultancy from our multidisciplinary team to address specific challenges

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:

Help you identify the need and scope of a pre-IND/INTERACT meeting with the FDA
Help you identify the need and scope of a Scientific Advice/Protocol Assistance/Innovation Task Force meetings with the EMA
Help you identify the need and scope of a Scientific Advice with EU National Health Authorities
Prepare the required documentation and logistics of such interaction with Health Authorities
Provide guidance on the scientific discussions, prepare, attend the meeting and write meeting minutes

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:

Why Choose Us for Your Regulatory Strategy and Target Product Profile?

Strategic Expertise: Rely on our seasoned team for tailored regulatory strategies designed to maximize opportunities and streamline processes.
Comprehensive Support: Benefit from our holistic approach, encompassing due diligence, gap analysis, roadmap development, and target product profile assistance.
Regulatory Insight: Access our deep regulatory knowledge and experience to navigate complex landscapes, ensuring informed decision-making and regulatory compliance.