Jane Allen Consulting, Inc.

Toxicology Services for Pharmaceutical and Biotechnology Clients


We provide a wide range of toxicology services to enable efficient drug development.


SPECIFIC TOXICOLOGY SERVICES:

  • Prepare or review nonclinical regulatory documents for FDA and European Medicines Agency, including nonclinical sections of

      • IND/NDA/BLA/CTA/MAA regulatory submissions,

      • Clinical Investigator Brochures and Prescribing Information,

      • Pre-IND meeting packages, end-of-Phase-2 packages, etc.

    • This service includes toxicological input and identification of any potential problem or risks associated with the document, in addition to actual writing/editing of the document(s). It includes identification and resolution of discrepancies in results between studies.

    • Independent 100% QC available.

  • Perform due-diligence on candidate drugs or potential company acquisitions.

  • Qualify impurity, intermediate, residual solvent, and excipient levels according to FDA and ICH guidance documents.

  • Special expertise in regulatory genetic toxicology.

  • Special expertise in alternative carcinogenicity (Tg.AC, Hras2, p53+/-) assays.

  • Manage all or part of toxicology study program:

    • CRO selection,

    • protocol design,

    • monitoring study conduct,

    • data analysis,

    • reporting.

  • Review or write reports when workload exceeds staff capabilities. Examples include completion of reports for retired staff, or staff on medical or maternity leave.

  • Develop non-clinical development plans and regulatory responses.

  • Prepare clients for FDA meetings. Accompany clients to meetings with regulatory authorities.

  • Write expert reports and white papers for regulatory agencies or laymen.

  • Attend scientific or FDA meetings, and prepare detailed reports highlighting issues of specific concern to client.

  • Confidential assessments of vulnerability to scientific fraud.