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Pharmaceutical Development

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.

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