Cilatus BioPharma

Regulatory Strategy and Submission Specialists

EU Affiliate and BREXIT Services

Deep Technical understanding and CMC Regulatory expertise

Regulatory Strategy

We are experienced in giving strategic regulatory advice and have worked with small, medium and large companies, managing all regulatory activities. Our expert team provides tailored global regulatory strategies for all stages of development.

EU Affiliate Services

We can act as EU affiliate for companies with no EU base/Regulatory team or for UK based companies dealing with Brexit. We provide full regulatory affairs support to manage your EU regulatory activities from development through to commercialisation and life cycle management. Our services include authoring, preparing and filing applications, integrating with your in-house teams to advise on EU regulatory requirements and liaising with Regulatory Authorities on your behalf.

Regulatory
CMC

Our regulatory experts have extensive CMC (Chemistry, Manufacturing & Control) experience with the broad global knowledge needed to effectively resolve regulatory CMC challenges and develop scientifically sound solutions. Let our expertise and experience in CMC, for large and small molecules help you to develop integrated CMC solutions for product development and approval.