At the heart of ForthTox's business is the toxicological consultancy for pharmaceutical development. Whether biological or new chemical entity, for human or veterinary pharmaceuticals, ForthTox can help you with the following:

Preclinical programme design and execution

• Reviews of published literature, e.g. to assess the studies needed to progress development of established compounds
• Formation and leadership of virtual development teams
• Troubleshooting of human/animal relevance of observed toxicity
• Preparation of documents for submission to regulatory authorities e.g. IMPD, Investigator Brochures, risk/benefit assessments, expert safety reports
• Outsourcing of studies to appropriate testing laboratories, study monitoring and report review
• Review of toxicological study reports and gap analysis
• Representation at Competent Authority meetings
• In-house training in toxicological requirements for successful submissions to EMA and FDA, e.g. ICH  and VICH guidelines
• ICH M7 compliant assessments
• Permitted Daily Exposure (PDE) document preparation

ForthTox has broad knowledge of the contract research industry and a wide range of contacts in pharmaceutical development and has, or can source, expertise in all the main areas of this exciting field. This has enabled the formation of a virtual team of highly experienced consultants who, working with company personnel, progressed a long established chemical from early assessment to an MHRA meeting and on to a Phase 2 clinical trial inside 12 months.

If your company is concerned about its pharmaceutical development or needs assistance with any of the above then please contact us.