Jane Allen Consulting, Inc.

Jane Allen Consulting, Inc. offers nonclinical consulting services to pharmaceutical, biotechnology and venture capital clients based in North America, Europe and Asia.

Jane S. Allen, Ph.D., Diplomate of the American Board of Toxicology (1984 - 2019), is the Principal of the firm with over 25 years’ experience in regulatory toxicology for drug discovery and drug development. She has broad-based experience in pharmaceutical toxicology with additional special expertise in genetic toxicology and alternative carcinogenicity assays.

The services of additional D.A.B.T.-boarded toxicologists are available to provide on-time delivery for larger projects. Consultation for ADME/DMPK, safety pharmacology, and CMC is also available from experienced nonclinical experts in those areas.

The firm provides both toxicology services to enable successful registration of pharmaceutical and biotechnology products (Regulatory Toxicology Services) as well as other services related to due-diligence, short-term projects for staff on leave, trip reports for scientific or regulatory meetings, etc.

Our track record includes:

  • Numerous successful IND, NDA, BLA, CTA, and MAA submissions in a variety of therapeutic areas.

  • High quality, cost-effective, timely preparation of regulatory submission documents, including CTD-formatted nonclinical sections of INDs and NDAs that are reviewer-friendly to facilitate use by regulatory agencies.

  • Due diligence for successful in-licensing of drugs in development.

  • Due diligence for acquisition or funding of pharmaceutical firms and nonclinical CROs.

  • Effective presentations to regulatory agencies.

  • Successful toxicological problem solving.

  • Confidential assessments of whether your firm/department may be vulnerable to scientific fraud.

Special Scientific Expertise: In recognition of Dr. Allen’s expertise in genetic toxicology, she was appointed a member of the US Pharma ICH Genetic Toxicology Task Force. She also has in-depth experience in alternative in vivo carcinogenicity assays such as Tg.AC, Hras2, p53+/ models.

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