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.
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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