Bespoke Analytical Testing Projects

Bespoke Analytical and Pharmaceutical Testing Services

At HMR Labs we’re passionate about ensuring your journey to batch release is devised to best suit your pharmaceutical products and formulations. We have spent over 35 years delivering pharmaceutical testing services as well as wider contract analytical testing services.

Our expanding techniques have led us to execute a number of custom pharmaceutical and analytical testing services which broaden our routine capabilities. HMR Labs is well placed to assist with wider bespoke projects and custom testing workflows.

With decades of expertise, our team of Analytical Scientists, Chemists, Technicians and method development experts can provide the consultancy and advisory support pharmaceutical and drug development companies need during their commercialisation and manufacturing journey.

Looking for assured guidance for internal quality control and GMP compliance, or to release your product with regulatory, FDA and MHRA approval? HMR Labs can work with you to identify the best method or approach to get you the data you need.

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Custom Batch Release Testing Journeys

HMR Labs can work with you to tailor various aspects of your batch release process to meet the specific needs of your pharmaceutical products and the regulatory requirements of various international markets.

All projects typically start with a plan to establish the testing methods required. Whether it’s development of a novel method, conducting a method transfer, method verification or the validation of a previously developed method, HMR Labs ensure that eachindividual test method will satisfy regulatory expectations.

Drug product safety and efficacy can then be evaluated in accordance with GMP, FDA and MHRA requirements as well as standard ICH and pharmacopeial protocols, whilst still having a central focus on the specific drug compound’s unique characteristics.

From tablets, capsules, inhaled products, oral liquids and other pharmaceuticals, HMR Labs services also cater for the wider GMP activities required to assure the quality and ongoing safety of pharmaceutical products, from manufacturing site validation and monitoring, ingredients analysis, container and packaging integrity testing and more.

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The Various Stages of Your Custom Batch Release Testing

Pharmaceutical and analytical testing services shouldn’t always be routine; partner with HMR Labs to develop a testing timeline that suits you:

Work with HMR Labs to define your requirements

Begin an initial consultation with our scientific team

HMR Labs will HELP DEVELOP A STRATEGY FOR ACHIEVING a custom batch release testing plan

All TESTING methods will be validated ACCORDING TO regulAtory REQUIREMENTS AND established in our labs

Devise a sampling plan that ensures an adequate supply of representative samples from each batch manufacture

Communicate directly with your scientific project manager involved in testing

Gain data that supports the release decision for every batch

Speak to a team member

Bespoke Analytical Testing Capabilities at HMR Labs

In addition to our portfolio of pharmaceutical and analytical testing services, HMR Labs provide a breadth of services which expand upon our routine testing capabilities.

If you’re looking for additional support for your manufacturing processes, including validation of cleanrooms, environmental monitoring or cleaning validation, we can supply a range of ongoing services or specific validation studies to ensure that the highest possible standards of cGMP compliance are maintained in your production areas.

HMR Labs take the time to carefully consider the planning and execution of method validation studies, technology transfers, method equivalence studies and more, to ensure successful outcomes.

With expansive knowledge and testing capabilities, HMR Labs is well equipped to provide a range of services including ICH stability and photodegradation studies. This expands to other environmental evaluations such as thermocycling (freeze/thaw) studies, temperature excursion studies and more.

We have a wealth of experience in supporting pharmaceutical companies with the in-vitro performance testing of finished products, such as bio-equivalence studies or comparative testing, as well as clinical testing requirements such as simulated patient use trials and human factors studies.