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.