Regulatory Affairs Toxicology

Non-clinical Safety Toxicology & CMC Services

When Experience Matters

The Peritus Toxicology Regulatory team has extensive industry and scientific experience – including EU / USA registered toxicologists, CMC specialists, pharmacologists and pre-clinical specialists from industry and clinical research organisations – enabling us to provide expert non-clinical evaluation, strategy development, study design, reporting and pre-clinical / non-clinical gap analysis & CMC services for therapeutics & medical devices.

Non-clinical Input Common Technical Documents
Non-clinical Inputs into Other Technical Documents
Chemistry Manufacturing Controls
Medical Device Safety & Biocompatibility
Toxicology Design, Monitoring & Reporting Services
Permitted Daily Exposure (PDE) Assessment
Regulatory Authorities Support Services
Expert Pathology Review and Assessments
Non-clinical Due Diligence & Data Review Services
Novel Non-animal in-vitro models for non-clinical testing
Non-clinical services for ATMPs Development
Other Non-clinical Safety Toxicology and CMC Services

Please contact us for support and questions in any non-clinical safety toxicology and CMC related to products and medical devices.

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