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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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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Skyepharma's analytical experienced team supports the pharmaceutical development during every phase of the development process. Analytical validation, characterization capabilities, stability analysis, ICH Q3D and E/L capabilities.

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We perform analytical development activities involving method development, impurities & degradation identification, compendial method verification, fate and purge studies etc.

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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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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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AMRI's laboratory team has extensive experience in designing and executing protocols for method development and validation, method verification and method transfer.

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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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Malladi’s Research & Development is well-equipped with a wide range of process & analytical capabilities such as method development & specification development for raw material/API, method validation, impurity identification and stability studies.

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We provide the study and validation of methods of analysis for the control of the active ingredient and its impurities, in both the raw material and the finished product.

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Our contract services group helps companies turn their new drug ideas into reality. Whether for phase I, phase II, phase III, or toxicology studies, we specialize in developing new synthetic routes while providing all necessary support to ensure regulatory compliance.

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To help you achieve the desired quality and performance of your compound, Recro’s veteran scientists customize solutions for your complex products. Our team adheres to global ICH guidelines to ensure the development of safe, effective, high-quality pharmaceutical products.

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ScinoPharm's comprehensive analytical services include purity testing, characterization of polymorphs, analytic methods development and validation, as well as stability testing. All analytical instruments and data are managed through the company's Laboratory Information Management System

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Unither can provide provide standalone pharmaceutical R&D services such as analytical methods validation, ICH stability studies, clinical batch manufacture, and clinical primary packaging.

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Uquifa offers the opportunity to manage the development activities of any drug life cycle by offering services on DMF/CTD/COS application, stability studies, process validation and analytical method validation, working standard supply or impurity

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Dishman's 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 (UV/CAD/RID-HPLC, GC, HS-GC), structural characterization (GC-MS, HPLC- MS, NMR, IR)

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Softigel's seven cutting-edge facilities house a fully integrated PDS unit and covers all product life cycle phases from early development to commercial in the same plant, using equipment replication between non GMP and GMP.

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Quantex Laboratories provides cost effective outsourced cGMP and GLP laboratory services to industry. Analytical methods developed include procedures for active pharmaceutical ingredients (APIs), drug formulations, cosmetics, personal care producuts, and raw materials.

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Our testing services are performed using USP/EP guidelines in compliance with FDA and DEA guidelines. Our laboratory is continually updated with new equipment to adapt to changing regulations and the ongoing needs of our clients.

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Our laboratories, equipped with the most modern instrumentation is operated by a well trained and highly motivated staff with an average of over 10 years of practical experience. The Pharmaceutical Analytical Laboratory is GMP inspected and under control of the respective authorities.

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Acceleration Laboratory Services is the foremost Contract Solutions Provider for the pharmaceutical research. The ultimate goal for our associates is to deliver superior solutions to our clients, on time, and on point, while maintaining a fun and empowering work environment.