DF Pre-Clinical Services Pty Ltd is based in Canberra, Australia and provides pre-clinical regulatory toxicology and drug development advice to Australian and international pharmaceutical/biotechnology companies.
Many small biotech and pharmaceutical companies have the capabilities to develop new molecules however require assistance in selecting a lead drug candidate (LDC) and moving the LDC into human clinical trials, and ultimately, to have their product registered. DF Pre-Clinical Services provides expertise in the following areas of drug development:
Ø Drug Candidate Selection
We can assist with:
- Preparation of strategy documents and programs for lead drug optimisation and drug candidate selection
- Contract Research Organisation (CRO) selection
- Contract management
- Project management
- Protocol development and review
- Report review
- Selection of formulation and chemical scale up facilities
Ø Pre-clinical Regulatory Toxicology Advice and Pre-clinical Program Developement
Once a drug development candidate is selected this service develops and manages the appropriate pre-clinical pharmacology and toxicology programs to support the conduct of clinical trials and to complete drug registration.
We can assist with:
- Pre-clinical strategy recommendations
- Pre-clinical toxicology program design and implementation
- CRO selection
- Contract management
- Project management
- Study protocol development and review
- Study monitoring
- Report review
Ø Pre-clinical Regulatory Interface
We can:
- Provide knowledge of pre-clinical regulatory guidelines
- Resolve regulatory toxicology issues
- Provide representation at Local and Overseas regulatory meetings
- Evaluate pre-clinical dossiers for completeness prior to submission to regulatory authorities
- Complete nonclinical modules of regulatory literature based submissions
Ø Other Services
- Review and audit pre-clinical toxicology protocols and studies
- Provide expert regulatory pre-clinical toxicology advice
- Provide independent toxicology data reviews for submission to regulatory authorities and Human Research Ethics Committees (HRECs)
- An extensive network of professionals to provide services outside areas of expertise
Principal consultant:
Dr Douglas Francis
Qualifications: BVSc, MVSc, PhD; UK/European registered toxicologist
Member of the US Society of Toxicology and British Toxicology Society, Member of the Roundtable of Toxicology Consultants.
Relevant Experience: Extensive experience working in government regulatory authorities and the pharmaceutical industry in the areas of pre-clinical toxicology and drug development.
Consultant:
Ms Tracey Brown
Qualifications: BSc, MSc; UK/European registered toxicologist
Relevant Experience: Extensive experience working in the pharmaceutical industry in the areas of pre-clinical toxicology.