A method is only as useful as the decisions it can support. We develop, validate and transfer analytical methods that are fit for the stage your programme is at — and that hold up when the stage changes.
PCL Research & Manufacturing has a proven record of excellence in developing analytical methods throughout the entire drug lifecycle. Our approach follows ICH guidelines, including preparation of validation protocols and reports to be shared and agreed with our clients.
The validation of each method will meet your quality needs at each development stage, providing cost-effective solutions. Full ICH validation on a method that will be replaced before first-in-human is money spent for nothing; an under-validated method carried into a filing is a finding waiting to happen. Matching the level of validation to the stage is the part that requires judgement.
Protocols and reports are agreed with you before execution, which avoids the common situation where a validation is completed to a standard nobody confirmed in advance.
Methods are built around the question they have to answer, whether that is release, stability, impurity control or process monitoring.
Quantitative methods for assay and content uniformity, with the accuracy and precision the specification requires.
Stability-indicating methods that resolve degradants and process impurities from the main peak and from each other.
Headspace gas chromatographic methods for residual solvents against ICH Q3C limits.
ICP-MS methods for elemental impurities following ICH Q3D, including risk assessment support.
Dissolution method development and validation, including discriminatory and biorelevant conditions.
Formal transfer of methods to or from your site or a third party, with comparative testing and a documented acceptance decision.
Development and validation are separate exercises, and treating them as one is the most common cause of a failed validation.
We establish what the method has to do — which analytes, which matrix, which limits, which stage — and agree the validation level appropriate to it.
Chromatographic or spectroscopic conditions are developed and optimised for resolution, sensitivity and run time, with robustness considered from the start.
For stability-indicating methods, the sample is deliberately degraded to confirm that the method separates and detects the degradants it will have to control.
A validation protocol is written and agreed with you before execution, specifying parameters, acceptance criteria and the rationale for each.
Validation is executed against the protocol: specificity, linearity, accuracy, precision, range, detection and quantitation limits, robustness and solution stability, as applicable.
A validation report is issued with all raw data, deviations and conclusions, and reviewed with your team.
Where the method is to be run elsewhere, a formal transfer is executed with comparative data and documented acceptance.
Method development draws on the full chromatographic and spectroscopic platform, including mass spectrometric detection for identification work.
The deliverable is the method itself, together with the documentation that lets anyone else run it and any authority accept it.
That depends on how the data will be used. Early development work often needs a qualified method rather than a fully validated one; anything supporting a filing or a release decision needs full ICH validation. We will recommend a level and explain the reasoning rather than default to the most expensive option.
Yes. We would start by reproducing it as written, which frequently identifies robustness issues worth resolving before validation begins rather than during it.
It has to separate and detect the degradation products the molecule actually forms. We establish that experimentally through forced degradation under thermal, hydrolytic, oxidative and photolytic stress, not by assertion.
Yes. Our facility is authorized to handle high-potency active pharmaceutical ingredients up to OEB5, and controlled substances under Ministry of Health authorization, under GMP certification issued by AIFA and following FDA inspection.
Turnaround depends on the type of analysis, the number of samples and whether methods already exist or have to be developed. We agree the timeline with you when the work is scoped, and tell you early if anything threatens it.
It depends on the techniques involved and on how many determinations are required. We confirm the exact quantity when we scope the work, and design the analytical plan around the material you have.
A detailed technical-scientific report with the methods used, the raw data, the results and their interpretation, issued under our quality system and suitable for inclusion in regulatory documentation.
Work starts only after a confidentiality agreement is in place. Samples, data and reports remain yours and are never shared or reused.
Tell us what the method has to support and at what stage. We will propose a development and validation plan matched to it.