CRS experts provide integrated services to support biopharmaceutical and medical device companies. We collaborate with regulatory experts to develop innovative and customised strategic programmes for clients focusing on regulatory milestones and clinical development planning and execution. CRS provides comprehensive planning to support strategic product development, regulatory liaison activities (e.g. submissions, scientific advice meetings), guidance to support preclinical and clinical research programmes, and GCP training.
Our professionals have extensive experience with the European Medicines Agency (EMA) and national European regulators as well as the US Food & Drug Administration (FDA).
CRS's services include:
- Setting up clinical study protocols and clinical development plans both in early and late-stage development
- Scientific advice meetings
- IND filing/CTA filing
- Integrated summaries on efficacy and safety regulatory meetings and representation
- End-of-Phase II meetings