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EXPERTISE

Location Settings

Asia-Pacific

AU -  Sydney
AU -  Melbourne
AU -  Brisbane
CN -  Hong Kong
CN -  Shanghai
IN -  Bangalore
MY -  Kuala Lumpur
PH -  Metro Manila
KR -  Seoul
CN -  Taipei City
TH -  Bangkok
NZ -  New Zealand

North America

US -  San Francisco
US -  Boston

GLOBAL

English

SOLUTIONS

RESOURCES

ABOUT US

Location Settings

Asia-Pacific

AU -  Sydney
AU -  Melbourne
AU -  Brisbane
CN -  Hong Kong
CN -  Shanghai
IN -  Bangalore
MY -  Kuala Lumpur
PH -  Metro Manila
KR -  Seoul
CN -  Taipei City
TH -  Bangkok
NZ -  New Zealand

North America

US -  San Francisco
US -  Boston

GLOBAL

English

Biodesk Clinical consulting

Worth Sharing?

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, 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

Product Experts:

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