Analytical testing is a critical part in every step of drug development and manufacturing. The qualitative and quantitative results generated from validated analytical testing provide first-hand information to control and ensure the quality and safety of raw materials, intermediates, and finished products. Like many other CMC (chemical, manufacturing and control) activities, analytical testing is also frequently outsourced. Many factors are attributed to this rapid market growth, including continuous outsourcing from pharmaceutical companies, growing pipelines for biological candidates, and increasing demand for more analytical details on drugs and process development by regulatory agencies. In response to the changing market dynamics, service providers are striving to provide analytical testing with quality, accuracy, and robustness all within tight timelines. As the contract research organizations (CROs) have become more integrated, small analytical labs need to establish their niche to succeed. Global contract analytical Laboratories provide QC laboratory analysis, method development, validation and expert advice for both finished products and raw materials for pharmaceutical and biopharmaceutical companies. Stability assay methods should be specific enough to differentiate between analytes and possible degradation products. The overall quality of drug-substance and drug-product batches placed on formal stability studies should represent the quality of materials used in clinical studies and of the quality of materials to be made at manufacturing scale. Supporting stability data can be provided using stability data generated from batches of drug substances and drug products made on a laboratory scale. Stability studies also should be conducted on material stored in a container–closure system that is the same as (or simulates) packaging proposed for real storage and distribution. Stability Studies are performed to understand the compounds/formulation in development: Physical & Chemical properties of API and drug product, Drug and excipient compatibility, Impact of manufacturing process steps, Interactions with packaging materials, Assignment of shelf life etc. Analytical stability programs for a drug substance or drug product also can be used for the characterization of impurities and related substances in line with dissolution studies, and to residual solvents, disintegration, and friability. Testing can be performed at ambient temperature, accelerated conditions, intermediate conditions, and other storage conditions. cGMP stability analyses include ICH Stability Services, Real-Time & Long Term Stability, Accelerated Stability, Forced Degradation Studies, Stress Stability Testing, R&D Stability Testing, In-Use Studies, Photostability, Comparative/Comparator Stability, Follow Up Stability Testing (FUST), Formulation Evaluation Stability, Finished Product Release, Cycling Chamber Stability Studies etc.

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Since its foundation, Quinta-Analytica has been providing a complete service of stability studies with active substances and dosage forms. Also these studies are conducted within the GMP framework and according to the ICH guidelines.

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Malladi’s R&D is well-equipped with a wide range of process & analytical capabilities such as method & development and validation for API, stability including stability studies, photostabiltiy studies, stress testing & degradation profiling.

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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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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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At CARBOGEN AMCIS AG, we can perform forced degradation tests, stress tests, and stability studies according to the International Conference on Harmonisation (ICH) guidelines.

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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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Our scientists at WellSpring have years of experience using advanced analytical equipment to ensure precision during all our testing procedures. Our facility is fully equipped with modern chemistry and microbiology laboratories that operate beyond cGMP standards.

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Crenza is a full scale R&D centre for development of Parenteral and Ophthalmic drug products. Crenza is founded by Industry professionals with invaluable experience and proven track record of development and commercialization of Parenteral and Ophthalmic drug products for regulated markets.

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Pace Analytical provides secure long- and short-term (accelerated) storage and stability testing to support your cGMP stability programs. We offer a broad range of conditions temperature only, temperature and humidity, photostability, cycling and freeze/thaw that supports ICH guidelines.

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The R&D Department is staffed with fully trained and highly experienced scientists and has at its disposal state-of-the-art facilities striving to produce products according to GMP/GLP global standards.

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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.

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Sequent Research is a leading Contract Research Organization that specializes in Analytical and Bio Analytical Services to support the API, Pharmaceutical, Personal Care, Institutional and Nutraceutical companies.

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GRAM Laboratories offers services for conduct of preformulation studies. These studies are performed to gather in-depth knowledge about the physical and chemical characteristics of the active ingredient and eventually aid in the development and optimization.

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We offer stability testing under International Conference on Harmonization (ICH) conditions and custom conditions.

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R.D. Laboratories maintains a large array of analytical instrumentation capable of performing a wide variety of procedures.

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Neopharm offers a full range of stability testing and storage services to meet the performance needs of our clients. Our stability operations include 15,000 cubic feet of walk-in/reach-in chambers/incubators that meet the ICH guidelines requirements.

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ICH-compliant stability storage temperatures and, where applicable, humidity control, with many intermediate options available.

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Analytical research and development (AR&D) offers standalone services and supports our formulation development activities.

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Megsan Labs is an USFDA inspected leading analytical testing laboratory, we focused and committed to deliver testing services to our costumers with excellence in quality, compliance and promptness

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Characterization studies for your product can be conducted prior to formulation. We specialize in the design and execution of pertinent pre-formulation activities required for successful pharmaceutical product development.

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All formulation services can be utilized independently or fully integrated within on-going services at Novick. These services include: Photo Stability Studies

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Characterization studies for your product can be conducted prior to formulation. We specialize in the design and execution of pertinent pre-formulation activities required for successful pharmaceutical product development.

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Stason has quality control systems, which require strict adherence to cGMP regulations. Total system quality is monitored from sample receipt to report generation. Offers QC testing for API’s, pharmaceutical intermediates, excipients & finished products.

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ChemCon carries out ICH-compliant stress and stability programs.

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Our services include Development of stability indicating methods, photostability, accelerated and long-term stability programs.

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Dalton supports its customers' products with our in-house stability services including full stability services from protocol development for accelerated stability, intermediate term stability and long term stability programs.

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GVK BIO performs stability analysis of drug products and active ingredient (APIs), packaging as per ICH, quality control testing and release as per cGMP requirements.

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Is the drug substance/product sensitive to light? Is this impact acceptable ? Are precautionary measures needed in manufacturing? Is a light resistant packaging mandatory? For all those questions, CEBIPHAR provides its support from protocol up to analyses