Analytical testing underpins every stage of pharmaceutical development. Without phase-appropriate methods, validated approaches and ICH-compliant stability data, programs risk delays in clinical progression, regulatory submission and commercial supply. As molecules move through the development life cycle, analytical strategies must evolve to meet shifting requirements – from foundational characterization in discovery through validation and life cycle management at commercial scale.

We provide comprehensive analytical support across the entire drug development life cycle, focused on the development of phase-appropriate, validated analytical methods and the delivery of ICH-compliant stability testing. Our integrated approach supports product quality, regulatory readiness and confident progression at every stage – from discovery through clinical supply and commercial manufacturing.

End-to-end analytical life cycle support

Discovery and preclinical development
At the earliest stages, analytical testing focuses on building foundational understanding to support downstream development decisions. This includes drug substance characterization, preformulation and early development studies, and initial development of analytical methods to support early programs.

Clinical development
During clinical development, analytical testing supports material quality, process understanding and regulatory requirements. This includes raw material testing, clinical trial material release testing, stability studies to support clinical supply, and analytical support for manufacturing process optimization.

Review and commercialization
As products move toward commercial supply, analytical testing supports validation, life cycle management and regulatory compliance. This includes manufacturing process validation support, product lifecycle and ongoing stability studies, and specialized testing such as extractables and leachables, nitrosamine assessment and elemental impurity analysis.

Why SGS?

As the world’s leading testing, inspection and certification company, our analytical testing services bring together specialist scientific expertise, ICH-compliant stability capabilities and validated method development across the full pharmaceutical development life cycle. Analytical work is integrated with our formulation development, clinical trial supply and GMP manufacturing services, providing seamless continuity as your program advances.

Backed by our global testing, inspection and certification expertise, we deliver the technical rigor, regulatory awareness and operational consistency required to support product quality and confident progression at every stage of development.