Porton’s highly skilled and experienced analytical R&D teams provide our clients with a full spectrum of RSM/INT/API development, validation, stability study and testing services that fully meet global IND/NDA regulatory expectations and client needs at different stages of drug development.

Method Development, Verification and Validation
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IND/NDA filing readiness; method development report; method monographs; validation reports per ICH guidelines.
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Systematic method screening system for rapid establishment of stability-indicating assay/impurity analysis method
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Chiral impurities and purity analysis methods (Chiral Method by HPLC or SFC)
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Counter-ion analysis methods (Titration or IC)
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Analytical methods for (potential) geno-toxic impurities (LC/MS/MS or GC/MS)
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Quick compound-specific residual solvent method development using in-house generic method as starting point
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Water Content by Karl Fischer
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Elemental impurities scanning and control method as per ICH Q3D
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Potency Assay or ID Test by NMR and others for qualitative analysis of impurities or impurity profile comparison work or reference standard characterization, as needed
Stability Study and Evaluation
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Forced degradation and stress tests (Light, acid, alkali, oxidation, high temperature, and high humidity)
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Stability test as per ICH Q1 and NMPA guidelines(40°C /75%RH,30°C /65%RH,25°C /60%RH,5°C)
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Generate protocols and reports applicable to IND filing
Analytical Testing
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Structural elucidation of standards and full characterization of primary standard with chromatographic purity, assay, ROI, LOD, water by KF, residual solvents etc.
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Certificate of Analysis (COA) available
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Preparation, structure elucidation and characterization of impurity
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Product release testing and support for process R&D
Quality Control Strategy
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Establishment of impurity control strategy with specification justification
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Research and establishment of quality standards of IND/NDA filing
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Technical support in life cycle management of analytical methods
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QRA, DoE and QbD study support