Biopharmaceutical industry consultants
Unit 1, 15 Station Road,
St Monans, KY10 2BL
Phone 01333 730170
Fax 01333 730782
Biological Consulting Europe (BCEU) Ltd is a provider of expert services for product development and regulatory compliance of human medicinal products.
BCEU provides the expertise required to comply with the regulatory requirements integral to the overall development process leading to successful commercialisation including:
- Scientific advice/protocol assistance procedures with the European Medicines Agency and national agencies;
- Orphan drug designations;
- Compliance with the paediatric regulations;
- Managing submissions for Clinical Trial Authorisation;
- Submission of Active Substance / Biologic Master Files;
- EDQM Certificates of Suitability;
- Assistance with Marketing Authorisation Applications.