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Analytical Method Development / Overview

Analytical >> Analytical Method Development >> Overview

Cebiphar had a considerable experience and knowledge in method development and validation for small molecules. Our objective is to provide our clients with the most tailored solution at each stage of their projects, and to ensure regulatory compliance.

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Analytical Validation

Analytical >> Analytical Method Development >> Method Development and Validation

In accordance with the ICH Q7 and the cGMP guidelines, DIVERCHIM validates the analytical methods developed by its teams to ensure registration and marketing authorizations by Health Agencies.

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Analytical Methods & Equipment Validation

Analytical >> Analytical Method Development >> Method Development and Validation

Our analytical centre provides these methods & equipment: Analytical methods and equipment are validated; LCMS, GCMS, HPLC, TLC; UV/VIS and IR spectrometry; Capillary electrophoresis; Thermal analysis – DSC, Calorimetry; NMR (400 MHz) + xRAY; PSD analysis

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Analytical Method Development & Validation

Analytical >> Analytical Method Development >> Method Development and Validation

State-of-the-art R&D center is located in our Ankleshwar facility. Highly qualified professionals with the scientific bent of mind are working in product development, analytical development and intellectual property rights.

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Analytical Method Development & Validation

Analytical >> Analytical Method Development >> Biologic Drugs

AMRI specializes in biochemical method development, transfer and validation for the analyses of biological products and biosimilars by HPLC, UPLC, LC-MS, MALDI-TOF MS, NMR and assays.

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Analytical Services for Material Characterization

Analytical >> Analytical Method Development >> Impurity Isolation and Identification

Dishman strives to provide a comprehensive portfolio of analytical services to facilitate this work. Analytical services support both process control and material characterisation for laboratory and production chemistry from initial raw material release to release of the final APIs.

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Analytical Development & Validation

Analytical >> Analytical Method Development >> Method Development and Validation

Our experienced team are here to deliver your custom small molecule API development projects on time, within budget and to the highest quality standards.

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Analytical Method Development

Analytical >> Analytical Method Development >> Method Development and Validation

With our vast experience we add exponential value to our client’s R&D programs at every stage of the drug development. We serve as a vital link between the pharmaceutical companies and the healthcare industry.

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Method Transfer & Validation

Analytical >> Analytical Method Development >> Method Development and Validation

Methods transfers are performed according to the GMP procedures and approved method transfer protocols. Similarly, method validations are also strictly performed according to the GMP procedures and approved validation protocols.

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Analytical Method Development & Validation

Analytical >> Analytical Method Development >> Method Development and Validation

Preparation of monographs, Development, validation and transfer of physicochemical methods, Stability indicating assay methods for active ingredients, degradation, products and preservatives, Discriminating dissolution tests, Determination of impurities.

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