Operating to GMP & ICH Q7 standards across all manufacturing sites
Analytical Sciences

Certainty in every result.

Method development and validation, release testing, stability studies, and impurity profiling aligned to USP, EP, and ICH expectations — so your data stands up to any review.

Overview

Analytics you can trust.

Our analytical teams characterize complex molecules with precision and build the validated methods that keep your release decisions defensible.

  • 01

    Method Development

    Fit-for-purpose methods designed around your molecule.

  • 02

    Validation

    ICH-aligned validation that withstands inspection.

  • 03

    Stability

    Programs that define and protect shelf life.

Capabilities

A complete analytical toolbox.

01

HPLC / UPLC

High-resolution separation for purity and assay.

02

Mass Spectrometry

ESI and MALDI for identity and structural confirmation.

03

NMR & Spectroscopy

Orthogonal structural characterization.

04

Amino-Acid Analysis

Net peptide content and composition.

05

Impurity Profiling

Detection, identification, and control of impurities.

06

Stability Studies

ICH-condition studies that define shelf life.

What's Included

From scope to report.

Method Development

Designed to fit.

  • Fit-for-purpose design
  • Robustness screening
  • Transfer-ready

Method Validation

ICH-aligned.

  • Accuracy & precision
  • Linearity & range
  • Specificity

Release & QC

Decision-ready.

  • Identity & purity
  • Assay & content
  • Counter-ion & water

Documentation

Audit-ready.

  • Analytical Data Sheets
  • Validation reports
  • Full traceability
Why GBL

Data that holds up.

Reliable Partnership

Experienced specialists and a rigorous quality system stand behind every batch we deliver.

Tailored Service

Your priorities drive the process, supported by attentive, first-class technical service.

Innovation & Technology

An integrated approach to innovation that keeps your products and timelines dependable.

Excellence & Quality

From small-scale to large-volume, GMP or non-GMP, every project gets tailored analytics and oversight.

How It Works

From scope to report.

Scope

We define the molecule, attributes, and acceptance criteria.

Develop

Methods are developed and screened for robustness.

Validate

ICH-aligned validation locks the method.

Report

Audit-ready documentation supports your decisions.

Start Your Project

Need analytics you can defend?

Tell us about your molecule and we will recommend the right analytical package within one business day.