BioDesk offers its clients one of the most experienced and cohesive regulatory, CMC and toxicology expert groups available across three continents.
BioDesk Clinical Consulting and
Global Regulatory Services
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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.
- 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