Expertly developed and validated methodologies are essential contributors to ensuring accurate, reliable and compliant analytical data.
HMR Labs can tailor this critical process to suit the specific requirements of the primary drug candidate and its intended use. As an MHRA-inspected laboratory, HMR Labs can offer versatile and bespoke pharmaceutical method development with cost-effective pricing and quick turnaround times.
Designing, optimising and refining analytical methods assures qualitative or quantitative measurements of substance parameters, including stability and potency. Meanwhile, evidential validation and assessment of these methods both certifies regulatory compliance as well as ensuring the reliability of collected analytical data.
Streamline batch release and accelerate your research with HMR Labs developing reputable analytical methodologies for ICH validation.
ICH compliant reports
generated on your behalf
Extensive knowledge of a
variety of dosage forms
Purpose built laboratories
housing a range of
qualified equipment
Pharmaceutical Analysis: Method Validation
Irrespective of the type of testing methodology, validating and verifying that the method will return accurate and reliable results involves a careful assessment of the specificity, linearity, precision and robustness.
The key ICH guidelines for validation shape HMR Labs’ services, with regulatory compliance being paramount to our customers. Pharmaceutical Method validation is a regulatory expectation we can assist with, by generating the documented evidence that is necessary for regulatory approval.
Inclusive of novel
drug compounds
cGMP testing
and analysis
Direct contact
with project manager
Flexible Services and Bespoke Projects
HMR Labs is dedicated to offering a flexible approach towards stability and analytical testing requirements. Many pharmaceutical manufacturers require robust and validated testing methodologies which are purpose built to suit their needs.
Pharmaceutical products also come in diverse formulations, dosage forms and active ingredients. By tailoring our services to align with each drug compound’s specific characteristics, HMR Labs can offer faster development timelines, cost effective refinement cycles and adherence to regulatory standards.
Pharmaceutical analytical testing can be optimised to achieve desired levels of sensitivity and accuracy which are critical for detecting low levels of impurities and APIs.
As well as pharmaceutical method development, HMR Labs can also validate the robustness of any developed method to ensure it is fit for purpose. All whilst continuing to produce reliable data across the product lifecycle.
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Contact us today to discuss your specific test requirements directly with our team of analytical scientists.
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