Analytical Development And Validation Services

Analytical Method Development, Method Validation, Method Transfers.

ABio-therapeutic development programs, including creation of protein candidates and antibody molecules requires extensive studies on physiochemical and biological function characterization.

Method development and validation of various drugs and pharmaceutical substances. Release and in-process testing Impurity profile studies Stability storage and testing Pre-formulation testing Analytical support for formulation development Compatibility studies Reference standard characterization Materials characterization Spectroscopy Our staff includes PhD professionals and research scientists, averaging 10+ years of core experience.

TYN BIOTECH is a reference service provider to pharmaceutical R&D laboratories for analytical development. Our objective is to provide the most adapted solution to our clients needs at each stage of their respective projects. Preparation of monographs and scientific data of active ingredients Development, validation and transfer of physico-chemical and microbiological methodsStability indicating analytical methods for active ingredients, synthesis impurities, degradation products and preservatives Discriminating dissolution tests Residual solvent determination Catalyst determination Microbiological quality Efficacy of antimicrobial conservation Microbiological dosages of Products/container interaction studies Geno toxicimpurities limit tests Cleaning control methods or validation We also offer the following studies Identification of impurities and degradation productsPreparation/qualification of reference substances Powder characterization: granulometry, thermic analysis, X-rays, specific surface, Multi-elements dosage

Corvid offers a comprehensive package of analytical services to support your product development and marketed product activities. Stability testing Finished product testing Pharmaceutical testing (USP, EP, JP, BP) Process contaminants, excipients, impurities, degradents Raw material testing.

dossierUSL has experienced team working towards compiling dossiers as per guidelines for various markets. We closely work with our clients and ensure that the dossiers meet their country regulatory standards. Dossiers contain all the notarized and legalized FDA and other essential documents as required by importer countries. We provide support for BE CT and also prepare dossiers as per ACTD guidelines for semi regulated markets. A dedicated team for dossiers and sample preparation has helped equip the dossier bank with over 250 dossiers. Our team works round the clock answering queries raised by concerned FDAs.

With the most modern GLP facilities Ansys provides a full range of analytical services that includes method development and validation, analytical testing release, stability study, and regulatory CMC documentation services. State-of-the-art instruments, leading-edge technologies, and experienced scientific staff ensures efficient, superior and cost-effective services with fast turnaround time. Ansys provides you comprehensive services with stability protocol design, program management, storage and testing, data trending/shelf life assessment up to dossier preparation for regulatory application at storage conditions according to pharmacopoeia monographs or customized specifications as per client requirements. Our team will support your pharmaceutical innovation program with methods for stability-indicating assay for related substances/ pharmaceutical impurity, methods for drug substance/API and drug products (tablets, capsules/liquid filled capsules, solution/suspension, powder, beads/coated beads, injectable, topical, solid dispersion formulations). We also will assist you with other specific methods, like dissolution (IR, ER, MR), residual solvents/ other volatile impurities, potential genotoxic impurity, leachable/extractable testing, cleaning validation, etc. Provide method development protocol, progress report, method validation protocol, report and/or standard testing procedures with full or customized release for API and drug product. AnSys experienced analytical development scientists can accelerate your development program by working hand in hand with our synthetic chemists thereby minimizing the overall time taken by your discovery and development program. Upon completion of the development, AnSys can qualify or validate the analytical test methods to your rigorous standards, including challenging the linearity, accuracy and precision of the methods, ensuring that the method performs over the desired range.

At Microtek We Develop Analytical Methods which are Robust, Reproducible and Transferable to the any corner of the globe. We expertise HPLC Method Development which plays crucial part in any product development, may it be Pharmaceutical, Additive, Formulation, Specialty Fine Chemical or Performance Chemicals. Besides HPLC We do develop Methods on GC, Spectroscopy and Classical (Volumetry, Gravimetry) Analysis.

Analytical Method Development for Assay, Content Uniformity, Related Substances, Dissolution etc.Analytical Method ValidationForced Degradation StudiesMethod and Site TransfersSpecification DevelopmentICH Stability Studies and Stability Sample AnalysisR&D Sample Analysis

Reliable and reproducible analytical methods are essential to both the pharmaceutical development process and the evaluation of drug products to meet the international standards. Analytical chemists will work to develop, qualify and validate methods or refine existing analytical methods to meet these demands. Fusion Scientific Laboratories analytical wing is focused on delivering the high end scientific solutions in the field of Formulation Developments Analytical Services. We provide support to organisations through state-of-art infrastructure and well qualified and experienced professionals. We provide analytical solutions to various industries like pharmaceuticals, FMCG, food and environmental studies. We constantly strive to provide quality services at all times to our esteemed clientele through our team of dedicated professionals.

Enem s Analytical Division is with well equipped state-of-the-art equipment. A high quality analytical development is essential to the success of any drug development effort. Our Analytical Development department focuses on robust methods which are suitable for validation and are readily transferable. Enem Nostrum has a specialized team in Analytical Services for supporting structure elucidation of metabolites, impurities/degradants as well asbioanalysis using specialized equipment and sophisticated software. Our development scientists possess substantial experience and expertise in the development, validation and transfer of analytical methods be it a stand-alone method that provides a key piece of information in a project, or an integrated suite of methods for support of comprehensive development. Our analytical capabilities include: Capability to carry out sensitive analysis of various APIs from different matrices, including plasma.A knowledge repository of more than 40 bio analytical methods required for the various BA/ BE pilot studies performed on our formulations.Sample clean-up procedures like liquid-liquid extraction, SPE, online SPE or automated SPE can be applied prior to analysis.In-house capacity to carry out Bio-Statistical analysis of our BA/ BE studies. Equipment: Ion-trap MS Detector This is used for Structure Elucidation of Metabolites and Impurity Profiling. Fully automated HPLC Systems Three (3) fully automated high throughput quaternary Gradient HPLC systems with UV detector (Shimadzu), and a binary gradient HPLC system with PDA detector, a very useful detector for method development, impurity profiling and forced degradation using HPLC. Sixteen (16) HPLC systems with various detector configurations such as UV, PDA, RI, Fluorescence detector (Agilent) High throughput RRLC with PDA detector (Agilent) Perkin Elmer UV-VIS spectrophotometer & JASCO spectrophotometer for method development, characterization and routine analysis. SM 2000 Particle Size Analyzer (Malvern) For particle size distribution in a sample over a range of 2 m to 2000 m.

Analytical Development

Trroy Life Sciences provides analytical research and development services for a wide range of chemical and pharmaceutical programs, incorporating full quality control and quality assurance support for all cGMP and non-cGMP manufacturing. Our Services Include Raw materials, intermediate finished product Custom pharmaceutical analysis Nutraceuticals, Herbal product analysis Analytical method development and validation as per ICH guidelines Characterizations of new molecules, impurity profiling, identification, and quantification Dissolution studies Stability studies water and food quality testing as per industry standards following GLP Spectroscopic structure confirmation Release testing Identification product and pathway Cleaning validation Physical property characterization

We do analytical method development and method validation for drug substance and drug product. Our analytical development services include: Method development and validation Stability Indicating Assays (Stress Degradation Studies) Assay and Impurity Profiling

We do analytical method development and method validation for drug substance and drug product. Our analytical development services include: Method development and validation Stability Indicating Assays (Stress Degradation Studies) Assay and Impurity Profiling

Indigo is a full-service commercial production company based in New York City. We manage every aspect of a commercial's physical production from creative development, casting, and scriptwriting, to shooting, editing, visual effects, graphics, voice-over, music, finishing, and broadcast delivery.

Unisoft has a team of resources that can help architecting business analytics solutions using Business Objects (BOBJ). They are experienced in rolling out rapid deployment solutions from SAP built over BOBJ. Our resources can provide following services: Business Analytics Solution architecture BOBJ data services-ETL application development Data Migration BI design using BOBJ Platform and Universe Dashboard/Reports design and development (BOBJ-SDK) BI Web Intelligence and BI Mobile

Callidus Research Laboratories is a leading provider of comprehensive pharmaceutical analytical development services. We are committed to partnering with pharmaceutical companies to ensure the quality, safety, and efficacy of their drug products. Our state-of-the-art laboratory, staffed with a team of skilled scientists and equipped with cutting-edge instrumentation, enables us to deliver precise and reliable analytical solutions tailored to your specific needs. At Callidus, our world-class analytical expertise empowers you to navigate the complexities of drug development with confidence

NLL offers a complete process and analytical development service to the pharmaceutical industry. A comprehensive package is available from early rote selection through bulk production and process validation.

Analysis of active and inactive pharmaceutical ingredients, Chemical intermediates, finished products based on compendial methods of IP, BP, Ph. Eur & USP.Also expertise in analysis of cosmetics. Involved as contributor to monographs to IP, BP, USP and evaluation of IP reference standards.Development and validation of analytical methods (as per ICH guidelines)Estimation of organic volatile impuritiesExecution of assay methods for and metabolites in biological matricesAssay of active ingredients from finished dosage formsOVI's & Investigational Analysis Using GC/MS with head space analyzerXRD crystallographyMeasurement of Surface Area incase excipients as per USPAAS Elemental Analysis Including Herbal Products for API, excipients, chemicals, Herbal productsThermal Analytical Systems (TGA/DTA/DSC) for investigational analytical profiles and polymorphic evaluationParticle Sizing Techniques and Evaluations for complete profiling of particle size distribution of powders, suspensions and inhalation productsParticulate matter analysis as per USP.

SERVICES Analytical Method Development Validation Impurity Profiling for drug substance drug product Multi Media Comparitive Dissolution Studies IVRT Studies for Topicals Stability Studies for all zones Forced Degradation Studies Stress Stability Studies UTILITIES Stability Chambers Milli-Q Ultra Pure Water System Mobile Phase Filtration Unit Induction Hot Plate, water baths, fume hoods EQUIPMENT HPLCs with UV,PDA RI Detector U.V. Spectrophotometer Dissolution Apparatus with auto sampler Diffusion Cell, Viscometers, Microscope

Dorizoe offers vast array of analytical services to the pharmaceutical industry. Our experienced staff has the right skill and knowledge to deliver high quality results. Analytical development department is engaged in: Analytical Method Development HPLC GC Ion Chromatography Non-chromatographic Methods Preformulation Compatibility Studies Impurity Profiling Stability Studies Analytical Method Validations We have the expertise in developing quality analytical methods for conventional and specialized dosage forms, including injectables, ophthalmics, oral liquids, and topical. Our solutions are robust, versatile and cost effective. Our formulation development team is supported by our talented analytical group, well-trained to address all aspects of analytical development.

We are engaged in rendering Analytical Services for Gases. These services are extremely admired among our consumers for their timely implementation. Our offered service is accomplished employing the advanced techniques. In addition, these services are rendered at reasonable prices.

Aadhaar Life, GLP lab performs method development and validation for a broad spectrum of pharmaceuticals and environmental dosage forms across all phases of pharmaceutical development. Our experienced scientists provide method development, experimental design, method validation protocol development, remedial method validation and customised method validation reports. Also, we have a full complement of state-of-the-art GLP analytical testing resources and expertise to perform release testing and quality control analyses for active pharmaceutical ingredients and drug products in virtually all dosage forms. ¿¿¿ Our Services Includes¿¿¿Method development and validation for chromatography techniques including HPLC, GC, Particle size and Microscopy with a variety of detection technologies including UV, DAD, FL, ELSD, RID, FID, 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, ointments, lotions, solutions, sprays, gels and powders. Method development, validation and quality control services for: Physical analysis including pH, viscosity, rheology, consistency, partial solubility, specific gravity and compatibility studies Organic volatile impurities Preservatives and antioxidants Clinical comparator innovator and test Analytical support for process and cleaning validation on various surfaces by HPLC and GC Dose verification for GLP studies