• Prepare or review nonclinical regulatory documents for FDA and European Medicines Agency.

This value-added service includes expert toxicological evaluation of potential problems and risks associated with documents for regulatory submission, including study reports. In addition to writing, we identify and resolve discrepancies in results between studies, between various sections of an NDA, between conclusions and data for a given study, etc. Independent 100% QC is available.

Types of documents include:

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

• Clinical Investigator Brochures and Prescribing Information,

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

• Regulatory responses and white papers

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

• Toxicological problem solving and commission-free referrals to experts.

• Develop non-clinical development plans.

• Prepare clients for meetings with regulatory authorities and accompany them to FDA, etc.

• Manage all or part of a toxicology study program:

  • CRO selection,

  • protocol design,

  • monitoring study conduct,

  • data analysis,

  • reporting.

• Special expertise in regulatory genetic toxicology.

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

• Experience with numerous therapeutic areas.