PHARMA

pharma lab

REACH Monitor offers expert Toxicological advice for the whole process within the pharmaceutical industry: from drug discovery to drug product commercialisation.

Our senior toxicology experts can deal with the most variated projects and prepare an Expert Report signed by a European Registered Toxicologist (ERT) for any Authority.

Regulatory field

    • Qualification of impurities and degradants, according to the ICH Guidelines:
    • Q3A(R2) Impurities in New Drug Substances
    • Q3B(R2) Impurities in New Drug Products
    • Q3C(R6) Guideline for Residual Solvent
    • M7(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
    • PDE (Permitted Daily Exposure) for the manufacture of medicinal products in shared facilities
    • Extractables and leachables: Toxicological profile and expert safety reports for setting acceptable limits
    • Safety Guideline: expert advice and monitoring of toxicological tests
    • Environmental Risk Assessment for pharmaceuticals (ERA)

 

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pharma

Research & Development

    • Prediction of toxicological profile by QSARs in an early research step:
    • screening within a molecules’ library
    • potential impurities, extractables and leachables
    • Substance substitution: solvents, raw materials, inert ingredients

 

 

Examples to highlight

Qualification of leachables in an implantable medical device

Identification and Qualification thresholds of impurities in a new Drug Product over the limit

PDE calculation for APIs (> 50)

Toxicological profile and acceptable limits calculation for inert ingredients

Safety evaluation for a Medical Device

Prediction of mutagenicity by QSARs for impurities

Identification of potential degradants and safety evaluation

Substitution of raw material in the pharmaceutical industry