BioDesk Welcome

BioDesk Clinical Consulting and
Global Regulatory Services

BioDesk offers its clients one of the most experienced and cohesive regulatory, CMC and toxicology expert groups available across three continents.

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The BioDesk team members have a combined experience across over 80 indications in 20+ therapeutic areas. The team has particular expertise in vaccines, stem cell therapies, cell and gene therapies, immunotherapies, ADCs, antibodies (incl. MAbs), GMOs, peptides and recombinant protein products.

Full time internal

Years of experience
on average

The team has experience
across 80+ indications
in 20+ therapeutic areas

Core Services

  • Drug and Clinical Development Planning
  • Regulatory Documents Preparation
  • Product Development Issues Resolution
  • Regulatory Plan Preparation
  • Clinical Trial Applications: CTAs/ INDs/ PIP, ODD
  • Marketing Authorisation Preparation/ Revision
  • Agency Interactions
  • Global Regulatory Services