Novotech 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.

Novotech'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