Regulatory and clinical consulting for biotechnology companies
As a division of Novotech and CNS, BioDesk provides expert consulting to biotechnology companies with regard to development and realisation of their Drug Development Plans (DDP) and global regulatory strategies driven by a highly experienced team based in Australia, Europe and the USA, covering:
- regulatory affairs consulting services.
BioDesk's core services include:
- Developing clinical and drug development plans for biotechnology companies
- Getting client’s products GMP-compliant and ready for clinical development
- Designing and co-ordinating client’s GLP- compliant toxicology studies in support of human studies.
- Co-ordinating meetings with International regulators, including US FDA and European EMA, and helping clients ask optimal questions in order to elicit meaningful responses.
- Writing up all types of applications to regulators pre-IND, IND, CTX: orphan applications, paediatric investigational plans, through to New Drug Applications
- Designing and writing protocols, investigator brochures and all modules in the Common Technical Dossier required for a marketing application
- cell and gene therapies
- Antibodies (incl. Mabs and ADC’s)
- peptides and recombinant protein products