Regulatory Development Consultancy

The development of new pharmaceuticals, medical devices and In Vitro Diagnostic Systems entails compliance with a regulatory framework that determines activities to be conducted. An understanding of the applicable regulatory framework since the early beginning is paramount to ensure appropriate optimisation of resources and decision making, allowing the process to be conducted in accordance with what regulators shall eventually demand. This strategic and consultancy service in regulatory affairs and development are designed for research institutions, academia, SMEs, spin-offs, startups and in general companies developing innovative components in the medicinal product and health product regulatory framework. Consultancy services in development involve, among others: a) Product regulatory classification for medicines and medical devices/IVDs, b) Regulatory Roadmaps up to Clinical Studies for medicines and up to CE marking, c) Intermediation with Regulatory authorities (engagement) to obtain feedback (SA AEMPS, Consultations for medical devices, Innovation office), d) Expert reports on specific contexts (regulatory strategy and requirements, development plans, etc.), e) Support in Regulatory Procedures (Orphan Drug Designations, Small Medium Enterprise), f) Training sessions and individualised coaching services on any of these subjects, and g) Regulatory coaching and mentoring, including individual sessions and training workshops. Deliverables are reports containing strategy, roadmaps, feedback from regulatory agencies depending on the purpose of the request. The service may be provided at any time point requested and the associated calendar agrees with the EIC beneficiary in accordance with project complexity.