CNS’ BioDesk is an expert consulting team offering CMC/manufacturing, toxicology, clinical and regulatory affairs consulting services for readying products to enter clinical trials or marketing approval.
The BioDesk team consists of experienced chemists, toxicologists, medical writers, regulatory affairs specialists and experienced clinicians based in Australia, Europe and the USA. BioDesk works closely with clients to design and implement manufacturing operations and non-clinical plans, mindful of commercial timelines and budgets.
BioDesk further adds value by ensuring that a global regulatory standard is inherent within client development programs.
BioDesk core services include:
- Developing clinical and drug development plans – always starting with the end in mind.
- Getting client’s products GMP-compliant and ready for the clinic.
- Designing and co-ordinating client’s GLP- compliant toxicology studies in support of human studies.
- Co-ordinating meetings with International regulators 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 and everything in between
- Designing and writing protocols, investigator brochures and all modules in the Common Technical Dossier required for a marketing application