Jane Allen Consulting, Inc.
Regulatory Toxicology and Technical Management Services

 

Toxicology Services for Pharmaceutical and Biotechnology Clients

We provide a wide range of regulatory and pharmaceutical discovery toxicology services to allow you to get your products to the market expeditiously.

Our capabilities include peer review of internal plans and regulatory documents to facilitate approval of submissions. This is especially helpful to firms with limited staff, in terms of providing a "second opinion" from an expert in regulatory toxicology.

Our toxicology services include:

  • Develop regulatory strategies.
  • Prepare non-clinical development plans.
  • Special expertise in regulatory genetic toxicology.
  • Special expertise in alternative carcinogenicity (Tg.AC, p53+/-, Hras2) assays.
  • Evaluate in-licensing candidates and perform due diligence.
  • Prepare or review out-licensing dossiers.
  • Write/review IND/NDA/PLA/CTX sections.
  • Review draft internal or contract reports and regulatory documents.
  • Advise on developability issues of lead compound candidates.
  • Advise on and prepare international regulatory responses.
  • Design or review protocols.
  • Interpret data.
  • Write integrated summaries and expert reports.
  • Prepare or review pre-IND meeting documents.
  • Scientific problem solving.
  • Write or review Clinical Investigator Brochures.
  • Presentations to FDA.
  • Attend scientific or FDA meetings, and prepare detailed reports highlighting issues of specific concern to you.
  • Prepare MSDS forms.

Home | Toxicology Services for Pharmaceutical and Biotechnology Clients | Toxicology Services for Chemical Firms and Trade Groups | Technical Management Services | GLP Compliance Services | About Us | Contact Us