Confidence Beyond Compliance

Regulatory bodies issue guidelines for companies developing Active Pharmaceutical Ingredients (APIs). Their main aim is to focus on the development of Acceptable Daily Exposure (ADE) values — also known as Permissible Daily Exposure (PDE) values.

This should eliminate possible risks from cross-contamination in the production of medicinal products. To ensure that your products are in line with these guidelines, we offer assistance in preparation and review of toxicological assessment reports – such as  permissible Daily Exposure (PDE) calculations & monographs, Occupational Exposure Limit (OEL) calculations & monographs for your APIs.

  • Diplomat of American Board of Toxicology (DABT) certified and Eurotox Registered Toxicologist (ERT)
  • PhD and Masters in pharmacology / toxicology qualification
  • Experience in drug discovery and development
  • Hands-on experience of in vitro and in vivo toxicology studies
  • Cosmetic safety assessment and health risk assessment to support the registration, evaluation
  • Generation of Toxicological Expert Statements on Impurities (TESI) for new substances
  • Good Laboratory Practice (GLP) inspections and pre-clinical CRO qualification
  • Toxicity study designing and study monitoring
  • Pharmacokinetic and toxicokinetic report review
  • In silico evaluations using QSAR tools
  • Support in preparation of ERA / EA, review & evaluation of existing data & literature