We structure critical transitions in research and development and reduce risk at the interfaces between science, clinical development, regulation, and commercialization.
Why phase transitions are critical
Many misjudgments in life science do not arise from insufficient scientific quality, but from the convergence of assumptions, data requirements, and stakeholder expectations. In addition, regulatory interactions and dossiers are not mere formalities. They directly influence whether study designs, evidence plans, and development roadmaps will be viable later on. For this reason, established instruments exist to obtain early guidance and avoid objections at later stages.
Our approach in research and development
Decision First instead of Trial and Error
Excellere does not act as purely scientific sparring partner, but as an integrated strategy and execution partner. We combine:
• Decision logic defining what must be decided when and why
• Evidence and development logic defining which data supports which decision
• Regulatory and dossier logic defining what must be documented in which form
• Commercial reality ensuring that clinical decisions do not lead into dead ends
Who this service area is most relevant for
Life Science Companies: Research driven companies facing a critical transition that must establish development, dossier, and regulatory logic early and consistently.
Investors: Investors who aim to steer portfolio companies through critical development phases, accelerate learning curves, and ensure that programs become regulatorily robust, decision ready, and industry compatible.
Our services along the phase transitions
Focus
Structuring the scientific hypothesis including the translational path and early risk and evidence logic.
Regulatory perspective
Derivation of evidence based questions that will later become relevant in scientific advice or pre IND discussions.
Focus
Clinical entry readiness, study design, critical decision gates, and integration of CMC, nonclinical, and clinical logic.
Regulatory perspective
Preparation of regulatory interactions including meeting and briefing strategy as well as documentation requirements.
Focus
Early integration of market access and commercial assumptions into clinical programs.
Regulatory perspective
Ensuring that clinical endpoints, populations, and evidence plans are not only medically sound but also consistent within regulatory, reimbursement and value argumentation contexts.
Focus
Steering growing programs, partner landscapes, governance structures, and decision processes.
Regulatory perspective
Ensuring scalable dossier readiness and documentation quality so that development, quality and CMC, nonclinical, clinical, and regulatory narratives remain consistent.
Typical deliverables
Strategy & Roadmaps
- Decision gate frameworks and prioritized roadmaps across development, regulatory and commercial dimensions
Regulatory Affairs & Dossiers
- Regulatory readiness checks and dossier storyline based on CTD oriented structuring principles
- Preparation and support of regulatory interactions including briefing and meeting packages and question and position strategies
- CTA and CTIS readiness at a high level including Part I and Part II logic, documentation requirements, and timelines
Clinical to Commercial Fit
- Analyses of endpoints, populations, and value logic to avoid later dead ends
Why Excellere
- Senior executive only approach
- Integrated perspective across research and development, clinical, regulatory, market access, and commercial functions
- Actionable roadmaps instead of theoretical slide collections
- Focus on decision quality and robust documentation logic
When a critical phase transition is approaching
Whether early development decisions, clinical entry, regulatory interaction, or scaling, let us jointly assess how Excellere can contribute to risk reduction and acceleration of your development.
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