Strategic Development Support Package

A structured assessment of available non-clinical data to identify gaps in relation to regulatory expectations. This includes reviewing pharmacology, PK/ADME and toxicology data to define what additional studies are needed for a full IND-enabling nonclinical program.

A structured assessment of available CMC data to identify gaps in relation to regulatory expectations. This includes reviewing drug substance and drug product specifications, formulations, impurity profiles, solubilities, manufacturing methods, stability etc. to define what additional data are needed for a full IND-enabling CMC program.

Development of a clear and pragmatic initial regulatory strategy tailored to the development stage, product maturity, and company goals. This includes identifying potential and optimal regulatory pathways, regulatory precedence, key regulatory milestones, and outlining potential risks and mitigations.

We handle interactions with FDA, EMA and local EU authorities, ensuring a well-aligned global and regional approach.

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A cross-functional workshop bringing together regulatory, clinical, and CMC expertises to define the most efficient development plan. The regulatory or clinical development lead may also act as a facilitator/project manager to the workshop, ensuring efficient planning and conduct.

Purpose:

• align across disciplines to ensure an integrated action plan
• discuss elements needed to progress into the next stage, for example:
- Target Product Profile (TPP)
- Clinical outcomes
- Paediatric plan
- Special designations (Orphan Drug, Fast Track/Breakthrough, PRIME etc.)

Define the most efficient and realistic execution approach

Format:
The workshop can be conducted either remotely (via Microsoft Teams) or physically.

Outcome:

• The outcome is a structured and aligned action plan, a roadmap for the next step in the development. The action plan outlines tasks to be executed and enables informed decision-making and efficient use of resources. 

Strategy Workshops can be held at any time during the drug development, whenever there is a need for reflection, trouble shooting, planning of activities, risk management or revision of existing plans.

Estimated effort per participant:
• 2-4 hours preparation
• 3 hours workshop participation
• 1 hour follow-up
Meeting minute review and potential follow-ups on discussion points

Total: 6-8 hours per person

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Preparation and execution of scientific advice meetings with authorities such as FDA, EMA, or national EU agencies. This includes defining key questions, submitting meeting request, preparing briefing package, and supporting the company throughout the interaction. Our team ensures that meetings are strategically planned and executed to maximize regulatory clarity and de-risk development.

Identification, evaluation, and selection of suitable CDMO and CRO partners to support manufacturing and clinical development. We support the full process from defining requirements and conducting due diligence to contract negotiations.

Design and development of clinical study protocols tailored to regulatory requirements and development objectives. This includes study design, endpoints, patient population, and operational considerations. Our clinical, medical writing, and regulatory experts work together to ensure robust, scientifically sound, and executable study designs aligned with FDA, EMA, and local EU regulatory agency expectations.

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Preparation and submission of clinical trial applications to relevant authorities (EMA, and/or national EU agencies) and/or initial IND to the FDA. This includes compilation of the CTA/IND dossier, coordination across functions and ensuring compliance with all regulatory requirements. We have an established collaboration with a US Agent, and can handle IND submissions and other regulatory activities with the US FDA.

We can provide tailored CTA/IND support as an integrated part of the Sponsor’s core team.

Use only what you need – or let us manage the process end to end

We offer targeted support for specific activities and access to a fully integrated, cross-functional team that scales with your project. Different roles are engaged as needed, with resource levels increasing around key milestones—such as regulatory submissions, study start-up, and data analysis—and decreasing in between.

Our flexible model ensures:
• Access to the right expertise at the right time
• Efficient and cost-effective use of resources
• Seamless coordination across all functions

Whether supporting individual tasks or driving the full development program, we act as a flexible partner aligned with FDA, EMA, and local EU regulatory requirements. We provide end-to-end support to enable efficient approvals and a smooth transition from planning to clinical execution.

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