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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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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

Among others, our analytical centre provides these methods and 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; Particle-size distribution 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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Method Development & Validation

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

AMRI's laboratory team has extensive experience in designing and executing protocols for method development and validation, method verification and method transfer — covering procedures for active pharmaceutical ingredients, drug formulations, cosmetics, personal care products and raw materials.

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Process Optimization FDA Audited

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

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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Validation Batches

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

We provide a full custom manufacturing service to customers looking for a flexible and qualified partner able to produce parenterals in accordance with their specifications. We work in strict accordance to the EU GMP, Good Distribution Practices (GDP), and documented Standard Operating Procedures

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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.

Analytical Method Development and Validation Before the analysis of leachables samples, a test method must be developed and validated to ensure that the analytes of interest are not obscured or affected by the formulation of the drug product. Appropriate analytes of interest for testing are to be dertermined. Drawing from resources available in literature, or performing extractables profiles in chemistry laboratory, specific analytes of interest for a drug product are determined. Methods are developed for these analytes in the presence of drug product, ensuring that any samples preparation procedures are incorporated into these methods. Following development, the method is then validated per ICH guidelines. Various studies involved in validation services include: linearity testing, precision (repeatability and intermediate precision testing), accuracy, specificity, limit of detection, limit of quantification, range, robustness and stability of test solutions. Different techniques with a multitude of drug product solutions are Gas chromatography (GC), Gas chromatography/mass spectroscopy (GC/MS), High-performance liquid chromatography (HPLC), High-performance liquid chromatography/mass spectroscopy (HPLC/MS), Inductively coupled plasma (ICP) spectroscopy, Ultraviolet/visible (UV/VIS) spectroscopy etc. New Sterilization Process Development and Characterization Solutions for FDA’s requirements for the testing required for a 510(k) submission for a new sterilization process can be provided by the laboratories. Biological and chemical indicators development, perform testing to prove that the sterilizer and sterilized materials are safe, and investigate the toxicity of any residuals. Laboratories GMP labs perform method development and validation for a broad spectrum of biopharmaceuticals and dosage forms across all phases of pharmaceutical development. Apart from method development, experimental design, method validation protocol development, gap analyses, remedial method validation and customized method validation reports may also be provided. Method development and validation for chromatography techniques including HPLC, UPLC, GC, SEC and IC with a variety of detection technologies including UV, DAD, FL, MS, ELSD, RI, PAD, FID, TCD, MALS, CAD Method development and validation for stability-indicating assays and related substances methods for drug substance and drug products, such as, tablets, capsules, suspensions, creams, injectables, nasal sprays, pMDIs, DPIs, medicated feeds, drug-eluting stents Method development, validation and quality control services for: Dissolution (IR, ER, MR), Organic volatile impurities, Preservatives and antioxidants, Clinical comparator assay and dissolution. Analytical support for process and cleaning validation on various surfaces by HPLC, UPLC, TOC and GC, Dose verification for GLP studies, Bioequivalency, in vitro pharmaceutical equivalency testing. Quality control support for Dosing solution analysis for toxicology studies, Customer product complaint testing, Field monitoring testing, Generation of statistical quality control charts.

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