Integrated Pharmaceutical Development Consultancy

This service provides tailored, end‑to‑end consultancy support to EIC beneficiaries developing advanced therapeutics and pharmaceutical products across all stages of development. The service targets innovators operating from early research to market entry, including EIC Pathfinder, Transition and Accelerator beneficiaries.

The consultancy covers six core domains: Chemistry, Manufacturing and Controls (CMC), Non‑Clinical, Clinical Development, Regulatory Affairs, Quality & Compliance, and Leadership & Project Management. Through a multidisciplinary team of senior experts, the service addresses key challenges including development strategy, risk mitigation, regulatory pathway definition, and operational execution.

The service is delivered in a flexible, project-specific format. Activities may include development strategy definition, target product profile design, regulatory and scientific advice preparation, clinical and non-clinical planning, quality system support, and due diligence activities. The team’s experience with EMA, FDA and national authorities ensures that regulatory strategies are grounded in practice, and that scientific advice interactions and submission activities are approached in a structured and effective way. Services are adapted to the needs and maturity of each innovation.

The goal is to accelerate development timelines, de-risk critical decisions, and support efficient progression towards clinical validation and market authorisation. EIC beneficiaries benefit from access to experienced consultants with deep industry expertise, providing actionable guidance and hands-on support.

The engagement is implemented through direct collaboration with in-house experts, ensuring continuity, responsiveness, and alignment with beneficiary objectives.