Method Development and Validation: a clear path to reliable analytical results

In the pharmaceutical, biotech and chemical industries, analytical testing plays a critical role in product quality, regulatory compliance and confident decision-making.

ALS supports clients throughout the full analytical method lifecycle, including method development, method validation, method verification and method transfer. With deep technical expertise, transparent communication and a quality-focused approach, we help ensure your methods are reliable, compliant and fit for purpose.

Why strong analytical methods matter

Robust analytical methods are essential for demonstrating that a product is safe, effective, consistent and compliant. Whether you are developing a new product, updating an existing formulation or transferring a method between laboratories, the method must be proven suitable for its intended use.

Method validation demonstrates that an analytical procedure performs as required by evaluating characteristics such as accuracy, precision, specificity, sensitivity and robustness. Suitabilitytesting further confirms that product-related interferences are identified and controlled, helping ensure your analytical data remain trustworthy.

How our team works with you

At ALS, we approach every project as a partnership. From the outset, we align with your product goals, timelines and regulatory requirements.

Understanding your product

We begin with a focused consultation to understand your product, analytical challenges and applicable regulatory expectations.

Designing a tailored validation plan

Based on your needs, we develop a customised plan covering analytical techniques, acceptance criteria and compliance requirements. Our work is aligned with relevant frameworks and monographs, including GMP, USP, Ph. Eur., ISO and ICH guidelines.

Laboratory execution

Your samples are analysed using established or newly developed methods in our accredited laboratories. Throughout the project, we maintain clear communication on findings, optimisation opportunities and any issues requiring joint decisions.

Reporting and method transfer

You receive a comprehensive, internally reviewed report together with a clear step-by-step method description. If adjustments are needed, we work with you to define the most appropriate next steps, including support for method transfer where relevant.

Our core analytical services

• Bioburden, TAMC and TYMC testing

We perform microbiological method work using membrane filtration or pour plate methods in accordance with Ph. Eur. 2.6.12 and USP <61>.

For medical devices, we also establish correction factors in accordance with SS-EN ISO 11737-1.

• Sterility testing

We support sterility test methods using membrane filtration and direct inoculation according to Ph. Eur. 2.6.1 and USP <71>.

• Bacterial endotoxin testing

We perform gel-clot and kinetic chromogenic methods in line with Ph. Eur. 2.6.14 and USP <85>.

Each method is tailored to your product characteristics, analytical objectives and regulatory needs.

Quality, sustainability and a lifecycle mindset

ALS integrates sustainability into analytical work by optimising laboratory resources and reducing the environmental footprint wherever possible. Our lifecycle-based approach supports long-term method robustness, risk reduction and readiness for ICH-aligned validation across development, transfer and routine use.

Partner with ALS

Whether you need full method development, analytical method validation for a complex pharmaceutical product, or suitability testing for medical devices, ALS provides reliable, regulatory-aligned and client-focused solutions.

Our experts are ready to help you move confidently from concept to compliant routine analysis.