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