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Certificates

With successful regulatory inspections spanning global markets, BioPharma can provide reliable, reputable data to support drug submission to multiple agencies for market authorization.

US FDA

Health Canada

EMA

World Health Organization

UK MHRA

French – ANSM , Danish – DKMA

ANVISA

Standards Council of Canada

As drug potency also increases, driving the need for sensitive methodologies to detect even lower concentrations of drug in biological samples, BioPharma utilizes state-of-the-art LC/MS/MS platforms to meet this need. The scope of bioanalytical services offered at BioPharma include:

  • Method feasibility

  • Method development (GLP and non-GLP) and validation

  • Method transfers

  • Bioanalysis of biological samples from BE/BA studies and clinical PK studies

  • Bioanalysis to support nonclinical toxicokinetic studies in all animal matrices

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