Toxicology / Virology (Biopharmaceutical Services)

Produce dossier-ready safety assessments in minutes. Specialist agents cover permitted daily exposure (PDE/ADE) monographs, occupational exposure limits (OEL), extractables and leachables risk assessments, nitrosamine risk evaluation and environmental risk assessment (ERA), each anchored to ICH, EMA, FDA a...

From early development, including mammalian cell line development, cell culture development, and process development, through to pre-clinical production and commercial supply, Patheon by Thermo Fisher Scientific provides CDMO services for protein-based biologic therapeutics. Patheon offers biotech and ...

More than 1,000 API substances PDEs have already been developed in house.
  New monographs are being developed on a constant basis.

Any PDE monograph can be developed upon request.

Our rates for PDE monographs are based on several factors such as status of development of the monogra...