Analytical method management
We offer end to end pharmaceutical analytical solutions that cover the full lifecycle of your product, from raw materials and APIs to excipients, drug substances and finished drug products. Whether you require custom method development and validation, analytical verification or method transfer services, our expert team ensures consistent, regulatory compliant results.
As drug developers push for faster transitions from discovery to market, method implementation becomes critical. A tailored and pragmatic approach to method
implementation helps accelerate timelines, reduce cost and enhance product robustness. At RSSL, we build flexibility into our methods from the start, enabling smooth progression from API to drug product and ensuring long-term sustainability across the product lifecycle.
We bring together a cross-laboratory, multi-disciplinary team, exceptional customer service and decades of experience, making us the ideal partner for pharmaceutical companies seeking analytical expertise.
Drawing on over 35 years of experience working with a diverse client base and a multitude of different dosage forms, we can support you in developing robust, fit for purpose methods appropriate for a vast range of key analysis areas including potency and assay development, purity and impurity profiling, stability indicating methods and physical characteristic.
Whether you require custom method development or non-compendial analytical solutions, we support every stage from sample preparation and extraction through to the latest regulatory requirements.
Method validation is performed when a new method is developed either by the client or analytical provider, an existing method undergoes significant modification or when no compendial method exists for the intended analysis. All validation is performed under a pre-approved protocol, with results compiled in a detailed validation report and test method documentation. RSSL can perform phase appropriate method validation according to the ICH Q2 (R2) and USP <1225> guidelines for the analytical procedure and also validate methods developed by other laboratories. The purpose of a method validation is to demonstrate the methods reliability in measuring the analyte within its defined scope, ensuring accuracy, precision or robustness.
Additionally, we can perform a gap analysis of previously validated methods to ensure they meet the current guidelines and maximise the likelihood of a successful regulatory filing. All our work is conducted according to the method parameters set out by the ICH guidelines.
Method verification is carried out to assess whether a procedure can be used at RSSL for its intended purpose, under the actual conditions of use for a specified raw material, drug substance, excipient or drug product.
The verification parameters can vary depending on the complexity of the analytical methodology, but it can be as simple as analysing a sample following the specified methodology in triplicate aligned with a client-approved protocol and documented in a verification report. The method verification service are commonly used for pharmacopoeial methods which have not been performed previously at RSSL for a particular client.
RSSL facilitates smooth and compliant analytical method transfer between sites, for example between laboratories, CRO's or from a development facility to a production environment. This service can be utilised for any methods, pharmacopeial or client, for which procedural and result consistency between sites must be established. Examples of types of method transfer include comparative testing, which ensures consistency between the sending and receiving laboratories, co-validation when both labs validate the method to establish equivalency or documentation review, which ensures that all method details have been clearly understood.
Every method transfer follows a clearly defined, client-approved protocol and is documented in a method transfer report. Whether you require custom method validation, methodology verification, or full analytical method lifecycle support, RSSL ensures consistent, regulatory-compliant results that stand up to scrutiny.
