Safety Evaluations

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Safety evaluations impurities

Controlling and toxicological assessment of impurities is mandatory in Drug substance development. We can support you on :

  • Risk assessment and qualification strategies for impurities in drug candidates and drug products according to the ICH Q3 guidelines.
  • Database & literature searches for genotoxicity and carcinogenicity data.
  • In silico toxicology assessment using (Q)SAR methodologies to predict mutagenic potential according to ICH M7 guideline.

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API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

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