Expert Services

Pharmaceuticals (GLP-bioanalysis)

Product development of novel pharmaceutical products requires reliable and reproducible analytical methods

That is why we develop tailor made LC MS analytical methods for bioanalysis which are highly sensitive reliable and reproducible. Our GLP compliance makes these methods directly suitable for your preclinical and clinical trials.

You are responsible for generating reliable data to support the safety and efficacy of your pharmaceutical product. Developing and validating bioanalytical methods under GLP is time consuming and highly regulated. Mistakes in data documentation or reporting can delay approvals and cost millions.

That is why we offer compliant high quality bioanalysis with clear reporting and fast communication so you can move forward with confidence.

INTRODUCTION

Reliable data for pharmaceutical development

GLP bioanalysis is essential for non clinical and clinical studies. It underpins key decisions in drug development and regulatory submission. Triskelion delivers high quality bioanalytical data compliant with GLP and aligned with EMA and FDA expectations.

Legislation

What rules apply

Bioanalysis for pharmaceuticals must comply with

  • OECD principles of Good Laboratory Practice GLP.
  • EMA and FDA bioanalytical method validation guidelines.
  • ICH M10 for method validation and sample analysis.

These rules ensure data integrity traceability and reliability across preclinical and clinical studies. Regulatory authorities demand full compliance for all pivotal studies used in registration dossiers.

What we do

Bioanalytical services under GLP

Triskelion supports pharma and biotech companies with:

  • Development and validation of bioanalytical methods LC MS MS.
  • Quantification of drugs metabolites and biomarkers in biological matrices.
  • Sample analysis for TK PK BA BE and toxicokinetic studies.
  • Study design advice protocol review and regulatory alignment.
  • GLP compliant data reporting raw data handling and archiving.
  • Fast track analysis and flexible capacity during critical phases.

Triskelion Expertise

Why clients choose us

We combine scientific accuracy with regulatory compliance:

  • Decades of experience in GLP bioanalysis for pharma.
  • Dedicated LC MS MS platform and flexible method development.
  • Transparent timelines and proactive communication.
  • Compliance with OECD GLP EMA FDA and ICH M10.
  • Direct contact with scientists for ongoing insight.

Learn more

Insights and methods

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Relevancy

Who is this relevant for

Our GLP bioanalysis services are ideal for

  • Pharmaceutical and biotech companies developing new drugs
  • CROs and CMOs needing external bioanalytical support
  • Regulatory affairs teams preparing clinical or non clinical dossiers
  • R&D teams requiring validated methods for API or metabolite quantification
  • Sponsors of TK PK BA BE and toxicology studies under GLP
  • Companies seeking flexible lab capacity with fast turnaround