Pharma and Biotech
Changes in the regulatory landscape have led to more stringent analysis of the toxicity of ingredients and finished products. ClinChoice has the know-how to author comprehensive reports and dossier sections that meet the guidelines and requirements set by health authorities.
Our services include:
- PDE-OEL assessment: Derivation of Permitted Daily Exposure (PDE)/Occupational Exposure Limits (OEL)
- Risk assessment of leachables from container closure system
- CTD writing: Preparation of Sections 2.4 and 2.6 as per ICH guidelines for safety– M4S R2
- Impurity qualification as per ICH requirements (ICH Q3 A to D and ICH M7)
- Risk Management Plan (RMP) and CCDS: drafting of non-clinical sections.
- Environmental risk assessment
- Other tasks: query-specific literature searches, ad-hoc product safety issues, and F-value derivation