Strategic Analytical Developments
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01Active’s Characteristics in a Drug Product
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02Physical, Chemical Characteristics of Excipients – Assessment and Compatibility Studies
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03Q1, Q2 and Q3 Studies (Generic and RLD Comparison)
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04Polymorph Quantification (as Impurity or Binary Mixture)
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05Characterization of Unknown Impurities and Elucidation of Structures
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06Extractables of Packaging Components
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07ICH Q3D – Elemental Impurities (Risk Assessment)
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08Toxicological Assessments
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09Carryover Impurities’ Assessment
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10API Sameness Studies
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Studies on Complex Formation Assessment in Formulation11
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Isolation/Separation/Characterization of Chemical Substances/Impurities/Ingredients12
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Polymer Qualifications (Qualitative and Quantitative) using GPC13
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Method Development (all Segments based on Critical Needs)14
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Method Validations as per ICH Q2 Guidelines15
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DMF/ANDA Support for Documentation/Experiments/Characterization16
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Impurity Profiling of API’s, Intermediates and FDF’s17
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ICH M7 – Genotoxicity Prediction and Assessment (API Projects and Others)18
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Risk Assessment for BA/BE Failures19
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