Pharmaceutical/OTC Actives and Consumer Products

FMD K&L offers a full array of services ensuring that your pharmaceutical/OTC actives and consumer products comply with global regulations
Toxicology Cosmetic Consumer Products
Our experienced toxicology professionals support your pharmaceutical/OTC actives and consumer product programs with a comprehensive range of toxicology services, including:
  • Cosmetic product safety reports (CPSR) & product information files (PIF):
    • Cosmetic product safety information & assessment
  • Toxicological assessments
    • Consultation to optimize toxicological assessment programs & minimize redundant testing
    • Comprehensive literature searches of public & commercial databases and analysis of toxicological data
    • Compilation & development of documents for submission to FDA, EU & other authorities, including formula assessment reports & raw material assessment reports
    • Quantitative skin sensitization risk assessment for allergens
  • Preparation of toxicological profiles for international nomenclature of cosmetic ingredients (INCI)
  • Estimation of the margin of safety (MoS) for all intended & unintended ingredients of cosmetic formulations
  • Systemic & local safety assessments of non-EU cosmetics
  • Calculation of MoS for California Proposition 65 chemicals
  • For pharmaceutical/OTC actives:
    • Calculation of permitted daily exposure (PDE) for pharmaceutical actives/excipients
    • Preparation of sections 2.4 & 2.6 as per ICH guideline for safety: M4S R2
    • Preparation of CCDS toxicology section (general toxicity, acute & repeated dose toxicity, genotoxicity, carcinogenicity, teratogenicity, fertility)

Our toxicology services are available individually or as part of an end-to-end solution. We are experienced with large-scale reformulation programs involving hundreds of products and short timelines.