CONSULTING ON ADVANCED BIOLOGICALS (CAB) Ltd is a specialist regulatory consultancy primarily serving the Regenerative Medicine Industry.  While our focus is European (EU/EEA) Regulatory Affairs, we have a good understanding of the US system and more importantly understand the differences.  Our clients are primarily biopharmaceutical/biotechnology companies but as small independent consultancy we can also offer affordable advice to universities, hospitals, and other non-commercial institutions.

With a strong background in biological medicinal products (monoclonal antibodies, recombinant proteins, blood products, vaccines, herbals) we have specialist knowledge in the area of advanced therapies (gene therapy, somatic cell therapy, and tissue engineering) including immunotherapies (cancer vaccines) and combination products.  CAB Ltd thrives on the regulatory challenges of technology interface products which may span medicine, blood, tissues and cells, medical devices, nanotechnology and even cosmetics.  Drawing on this broad understanding of interrelated regulatory systems we can help you understand how your complex healthcare product will be regulated and hence assist our clients to develop their European business strategy.

Our principal consultant, Dr Christopher Bravery, is an ex-agency (MHRA) Quality (CMC) assessor who worked primarily on Centralised (EMA) procedures.   In this capacity Christopher was a member of the European Medicines Agency’s (EMA) Cell Products Working Party (CPWP) of the CHMP and an author of the principal guideline for cell-based medicinal products.

CAB Ltd can support your organisation through all phases of development from initial agency interactions to Market Authorisation and beyond.  CAB Ltd offers a range of advice and assistance, including:

Evolving regulatory requirements

  • Borderline classification
  • Regulatory strategy
  • Product and process development
  • Scientific and Regulatory due diligence
  • Agency Interactions (National and EMA)
    • Classification
    • Orphan Drug Designation
    • Informal Agency Meetings
    • Scientific Advice/Protocol Assistance
    • Clinical Trial Applications
    • Market Authorisation Applications

 

Registered office, Units 15 &16, 7 Wenlock Road, London N1 7SL.  Consulting on Advanced Biologicals Ltd is registered in England and Wales (registration number 07035115).