Novotech 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:

  • CMC/manufacturing,
  • toxicology,
  • clinical,
  • medical
  • 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, CTA: 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

Product Experts:

  • Vaccines
  • cell and gene therapies
  • immunotherapies
  • Antibodies (incl. Mabs and ADC’s)
  • GMOs
  • peptides and recombinant protein products

 

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