PHARMA

PHARMA

We offer services in risk assessment and toxicological consulting services, in the fulfillment of regulatory requirements along the development and life of the drug.

SERVICES
  • Human health risk assessment and estimation of safe threshold, i.e. Permitted Daily Exposure (PDE) and Occupational Exposure Limit (OEL)
  • Toxicological evaluation of impurities to identify main concerns in order to be compliant with ICH guidelines, e.g. M7 (Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk), Q3A (Impurities in new drug substances), Q3B (Impurities in new drug products), Q3D (Guideline for elemental impurities) and Q6A (Specifications test procedures and acceptance criteria for new drug substances and new drug products: chemical substances)
  • Risk assessment following to quality issues, i.e. contamination, in the lifecycle of the drug product
  • Environmental Risk Assessment (ERA) report
  • Reviews of published literature of toxicological data and evaluation of toxicological profile
  • In silico predictions and Threshold of Toxicological Concern (TTC) approach
  • Dossier strategy evaluation to identify the studies needed to fulfill regulatory requirements
  • Contracting out and monitoring of new tests and report review
  • REACH registration of pharmaceutical intermediates (on-site isolated > 1 t/y, transported isolated 1-1000 t/y and transported isolated > 1000 t/y)

VANESSA ALBERTI
AREA RESPONSIBLE
VANESSA ALBERTI
Regulatory Affairs Specialist

vanessa.alberti@kahlbergconsulting.com

Phone +39 02 6700319