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01 126Overview
02 27Photostability
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01 1Cayman Chemical Company Inc
02 2Renejix
03 1Century Pharmaceuticals
04 1ACTA Laboratories Inc
05 1AVIZ Laboratories
06 3Acceleration Laboratory Services
07 1Admix Pharma Laboratories, LLC
08 1Aenova Group
09 4Aizant Drug Research Solutions Pvt. Ltd.
10 1AlbyPharma
11 2Anacipher
12 7Aragen Life Sciences
13 1Arbro Pharmaceuticals Pvt. Ltd
14 1Ash Stevens, Inc.
15 1Avaca Pharma
16 1Bahrain Pharma
17 1Biolink LifeSciences
18 1BirgiMefar Group
19 1Bluepharma
20 1Boston Analytical
21 1CARBOGEN AMCIS AG
22 1CLEARSYNTH LABS LIMITED
23 1Cambrex Corporation
24 3Cebiphar
25 1ChemCon GmbH
26 2Chromcore Lifesciences
27 1Cook Pharmica LLC.
28 2Crenza Pharma
29 2Curida AS
30 1Cyndea Pharma S.L
31 9Dalton Pharma Services
32 1Dannalab B.V
33 1Delorbis Pharmaceuticals
34 2Dishman Carbogen Amcis
35 2Eurofins CDMO
36 1Farbe Firma
37 1Flagship Biotech International Pvt. Ltd
38 1Fresenius SE & Co. KGaA
39 1GALENIX INNOVATIONS
40 1GALIEN LPS
41 1GBI
42 8GRAM Laboratory Inc
43 1Globela Pharma
44 1Gracure Pharmaceuticals Limited
45 1JGL d.d
46 1Jubilant HollisterStier
47 1Labiana Life Sciences S.A
48 1LakePharma
49 2Lamda Laboratories
50 1Legacy Pharmaceuticals Switzerland
51 1Lonza Capsugel
52 2Lubrizol Life Science Health
53 3Megsan Labs Private Limited
54 1Merck Millipore
55 2Mithra CDMO
56 3Neopharm Labs Inc
57 1Novick Biosciences
58 1Nutrasource
59 1ORIT LABS LLC
60 1Onyx Scientific
61 1PCI Pharma Services
62 1PSR Pharma Science and Research
63 1PYRAMID Laboratories, Inc
64 9Pace Analytical Services, LLC
65 1PharmaVize NV
66 1Pharmatis
67 1Primera Analytical Solutions Corp
68 5QUINTA-ANALYTICA s.r.o
69 1Quantex Laboratories
70 2RD Laboratories
71 1Rafarm S.A
72 2Ropack Inc
73 2SEQUENT SCIENTIFIC LTD
74 1STABICON LIFE SCIENCE PVT LTD
75 1Saneca Pharmaceuticals
76 1Santa S.A
77 1ScinoPharm Taiwan, Ltd
78 2Servier
79 1Siegfried AG
80 2Softigel Procaps
81 3Stason Pharmaceuticals, Inc.
82 1Sterin Labs
83 1Sushen Medicamentos Pvt. Ltd
84 1Tepnel Pharma Services
85 1UPM Pharmaceuticals
86 1UQUIFA
87 1Vitas Analytical Services
88 2WellSpring
89 1Wyjolab-Arysta
90 1Zenvision Pharma LLP
91 1mKnal Global Solutions
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24 50U.S.A
25 2United Kingdom
Pharma Service : Analytical
STABILITY STUDIES/FORCED DEGRADATION STU...
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 complian...
Category : Stability Studies
Sub Category : Overview
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Renejix: CDMO with expertise in small molecule oral dosage, delivery tech, and multi-modality manufacturing.
STABILITY STUDIES
Renejix offers stability studies for every phase of drug development including clinical trials, registration & commercialization. It provides a wide range of analytical services such as photostability testing, forced degradation studies, etc.
Century has been an API manufacturer for over 30 years & is the partner of choice for multipurpose custom manufacturing projects.
Century Pharmaceuticals conducts contract stability study services for active pharmaceutical ingredients (APIs) and biotechnology products under various temperature conditions.
PHOTOSTABILITY TESTING
Renejix offers a wide range of analytical services such as photostability testing, formulation evaluation stability testing, statistical analysis and data trending, and forced degradation studies.
Sub Category : Photostability
STABILITY TESTING
With Admix Pharma Laboratories, LLC you will enjoy a host of attractive benefits that can effectively extend your in-house pharmaceutical products development and manufacturing capabilities for long and short term projects.
ICH STABILITY STUDIES
We perform ICH stability studies on drug substance and /or dosage form. Studies are conducted according to the Stability Study Protocols and fully under GMP conditions.
ICH COMPLIANT STABILITY STUDIES
JGL laboratories are equipped for development and validation of analytical methods, stability monitoring of developmental formulations and finished products in accordance with ICH/MENA/ASEAN guidelines.
Uquifa has capabilities for stability studies, impurity profile characterization, process transfer, reference standards synthesis, process transfer, polymorphism studies,etc.
Galien LPS offers analytical services which covers: Stability studies ICH and On-going; Analyses of raw materials and finished products; Optimization and modernization of methods , HPLC to UPLC transposition ; Validation; Reports, trend analysis.
Primera specializes in customized analytical method development, transfer and validation using state-of-the-art analytical tools. We also provide cGMP Sample Storage and testing services. With no observations and no 483 findings from two FDA audits, We are in full ...
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.
ICH-COMPLIANT STABILITY STUDIES
Each of our plants has qualified in-house climate chambers and can do ICH-compliant stability studies, using carefully set conditions depending on product characteristics, regulatory requirements and the desired shelf life.
STABILITY STORAGE FOR ALL KEY ICH CLIMAT...
Offering stability storage for all key ICH climatic zones. Our available conditions and storage solutions are suitable for long term, intermediate, accelerated, photo-stability, in-use and FUST stability trials.
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 res...
STABILITY TEST
CLEARSYNTH efforts focus from the pre-clinical stage through to phase III and to the successful technology transfer to manufacturing locations throughout the world.
We have a dedicated stability and analysis group at our laboratory, Diteba, providing comprehensive support for all stages of drug development, including early research and development to commercial or post-approval studies.
STABILITY STORAGE & TESTING
Our skilled and competent Chemistry group uses a wide range of methods to test raw materials, FDFs and packaging components in accordance with compendial procedures including but not limited to: USP/NF, BP, Ph. Eur, JP, CP, FCC, ACS, AOAC, AOCS, In-house and client...
We have a well-equipped laboratory and are capable of handling wide variety of all generic injectable formulations. In addition, we are well equipped to conduct stability studies right from the lab scale through the commercial scale.
Stability studies & Analytical Method Validations & Process Validation Scale-up batch production.
STABILITY STUDIES AS PER ICH GUIDELINE
Gracure's facility has capability to manufacture tables, hard gelatin capsules, oral liquids, dry powder syrups, and ointments. The facility is designed for serving International market.
SUSHEN Medicamentos (SUSHEN), is a global company of end-to-end pharmaceutical services with focus on drug delivery research and product development. SUSHEN’s expertise can bring a complex formulation project in to clinical and bioequivalence with superior qualit...
LONG-TERM, INTERMEDIATE & ACCELERATED IC...
At DELORBIS, we are equipped with stability chambers that enable us to conduct ICH stability studies at long-term, intermediate and accelerated conditions.
SOLID-STATE & SOLUTION-STATE STABILITY
Our dedicated team of scientists have their core training in the area of preformulation and have expertise in the complete pharmaceutical profiling of molecules.
ICH COMPLIANT STABILITY PROGRAMS
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.
STABILITY AND SHELF LIFE SERVICES
Quantex Laboratories offers a complete range of stability testing services to assist you with your stability testing requirements. We have numerous temperature and humidity conditions available in our qualified stability storage chambers, including all conditions n...
SAXS FOR STABILITY STUDIES
Information about the structural parameters obtained from the SAXS measurements, such as envelope shape and invariants (mass and radius of gyration), serve as important markers that are correlated with biological activity.
cGMP COMPLIANT STABILITY STUDY PROTOCOLS
ACTA can write stability protocols for you or provide assistance to ensure your stability projects are fully cGMP compliant and meet the stringent requirements of the FDA. ACTA tracks your stability projects carefully to ensure that they are tested in a timely mann...
PHOTO STABILITY STUDIES
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 produ...
PHOTOSTABILITY STUDIES
Our integrated product development services help biopharmaceutical companies shorten time to market, manage risk and access new global markets to maximize portfolio value.
STABILITY STUDIES IN ICH GUIDELINE-CHAMB...
Our GMP-compliant facility is fully equipped to conduct stability tests throughout the development process (real or accelerated) or on-going tests. Wyjolab offers large, climate-controlled storage facilities that comply with ICH guidelines.
ICH & ON-GOING STABILITIES
Pharmatis has been conceiving and developing various recipes, processes and drugs for many years. Pharmatis offers a wide range of industrial developments.
ICH Q3B COMPLIANT STABILITY OR FORCED DE...
We offer stability testing under International Conference on Harmonization (ICH) conditions and custom conditions, Which includes bulk holding time, Freeze/thaw studies, Informal, formal, accelerated and long-term stability conditions & ICH or custom conditions.
STABILITY TESTING FOR FINISHED PRODUCTS
Bahrain Pharma have excellent analytical services including stability testing for finished products, raw materials, in process materials and other Pharmaceutical or Nutraceutical materials.
STABILITY STUDIES - STRESS TEST STUDIES
We offer full service solutions and project management for cost effective product development in pharmaceutical as well as food /nutraceutical areas.
comprises of analytical testing laboratories and formulation development areas operating under cGLP and cGMP. Orit has a number of products already approved and marketed, with several additional products already filed and under FDA review.
ICH STABILITY (5° C, 25° C/60% RH, 30...
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 en...
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.
ICH PHOTOSTABILITY
Our finished dosage form development team has successfully created numerous control release and extended release formulations, successfully ensuring afterward rapid scale up to full production.
Ash Stevens has a dedicated and experienced analytical department providing comprehensive support from early-stage development to commercial API manufacturing.
PHOTO STABILITY (UV & DAYLIGHT) PER ICH ...
GLP STABILITY STUDIES
Additionally, Curida offers following services across all technologies: Stability studies
PHOTOSTABILITY EVALUATION
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.
STRESSING TESTS & PHOTOSTABILITY STUDIES
Dishman offers various analytical services under Stability which includes ICH Stability Studies, Stressing Studies, Photostability Studies, Drug Substance & Drug Product Stability and Degradation profiling.
CONDUCTING STABILITY STUDIES
Flagship biotech had established A state-of-art Research and Development Centre (R&D) at Mumbai - focused towards developing new products, improving existing products as well as drug delivery systems and expanding product applications.
Our services include the development & validation of analytical methods. We identify by-products and determine polymorphic product forms's broad portfolio of analytical methods includes HPLC(-MS), CE, GC(-MS), FT-IR, NMR, particle size determination etc.
ICH STABILITY STUDIES/DEGRADATION PROFIL...
STABILITY STUDIES FOR SHELF LIFE ESTIMAT...
Stability testing is integral to developing new pharmaceutical products and active pharmaceutical ingredients, to establish their shelf life or expiry date. We provide a complete solution to your requirements of Stability Studies for Shelf Life Estimation.
FORCED DEGRADATION STUDIES - ACID, BASE,...
DRUG PRODUCT PHOTOSTABILITY STUDIES
We offer stability testing under International Conference on Harmonization (ICH) conditions and custom conditions.
STABILITY STUDIES OF LIQUID OR LYOPHILIZ...
Cook Pharmica product development organization develops processes, methods and formulations that support and improve the manufacturability and stability of our clients’ products. From early cell culture scientists to analytical specialists.
STEREOCHEMICAL STABILITY
We help in stereochemical stability, chemical and physical stability of polymorphs, and structure elucidation based on LC/MS and chemistry.
STABILITY STORAGE CHAMBERS
R.D. Laboratories, Inc. has an extensive array of GC capabilities. Because of our extensive experience and capabilities, customers rely on us for all of their compedial residual solvents testing, client specific methods and residual solvent validations.
R.D. Laboratories maintains a large array of analytical instrumentation capable of performing a wide variety of procedures.
At PSR we have a dedicated group of qualified personnel to conduct stability studies of drug products and substances in compliance with ICH guidelines.
CHEMICAL & PHYSICAL STABILITY OF POLYMOR...
STABILITY STUDIES FOR BULK APIs/FORMULAT...
ScinoPharm's comprehensive analytical services include purity testing, characterization of polymorphs, analytic methods development & validation, & stability testing. All analytical instruments & data are managed through the company's LIMS.
Zenvision has standalone analytical services including complete analytical support for dossier filing.
ChemCon offers stability studies according to ICH Q1A. It provides long-term stability testing, accelerated stability, stress & forced degradation studies, photostability tests, etc.
Curida offers services within storage, monitoring, and analytical testing and documentation. We have several climatic chambers available, such as cold and cool storage rooms.
PHOTOSTABILITY (ICH Q1B, OPTION II)
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.
NARCOTICS STABILITY STUDIES
ICH & FDA COMPLIANT STABILITY TESTING FO...
Our stability samples are housed in ICH compliant storage chambers. All chambers and rooms are mapped, monitored for temperature and humidity, alarmed, and backed up with emergency power to ensure accurate results.
STABILITY-INDICATING ASSAY
From early strategic investigative work on possible formulations to the development and implementation of methods and the generation of regulatory submission data, our team of experienced scientists will work – and communicate – with you at every step.
RESIDUAL MOISTURE STABILITY STUDIES
GRAM Laboratories offers development of a clinically relevant and more stable formulation. This is made possible because of the knowledge gained from preformulation evaluation. Formulation studies are customized to achieve the most appropriate formulation in a time...
ZETA POTENTIAL DETERMINATION
Our ICH stability storage facilities consist of over 100 m3 of walk-in stability rooms, fully secured with 24/7 electronic monitoring, alarm and backup power.
SUSPENSION & EMULSION STABILITY STUDIES
PHOTOSTABILTY
ICH-compliant stability storage temperatures and, where applicable, humidity control, with many intermediate options available.
STATISTICAL ANALYSIS OF STABILITY DATA
Eurofins performs ICH compliant stability studies including stress studies, accelerated and long-term stability studies to support regulatory CMC programs and process development.
STABILITY CABINETS
Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Stability Cabinets - temperature/humidity/light exposure testing compliant with ICH guidelines.
STABILITY OF STANDARD PREPARATIONS
GRAM Laboratories offers all analytical methods are validated as per the ICH guidelines. Compendial methods when used for analysis of stability samples are also validated as per ICH guidelines. The following parameters are challenged during the validation process.
STABILITY CHAMBERS
Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Stability Chambers - 25°C/60%; 30°C/65%; 30°C/75%, 40°C/75%, 5°C and others compliant with ICH guidelines.
Eurofins offers ICH photostability testing capability including stability studies including stress studies, accelerated and long-term stability studies to support regulatory CMC programs and process development.
STABILITY OF SAMPLE PREPARATIONS
Stabicon offer Stability Study Services to support all phases of Drug Development.
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 with photostabiity chambers
Analytical research and development (AR&D) offers standalone services and supports our formulation development activities. Aizant offers GLP compliant ICH stability testing services.
Analytical research and development (AR&D) offers standalone services and supports our formulation development activities.
FORCED DEGRADATION STUDIES
STABILITY ANALYSIS OF DRUG PRODUCTS
LakePharma utilizes CE-SDS, SEC-HPLC, DSC, intact mass, peptide mapping, and cIEF assays to examine the integrity and stability of antibodies under different conditions. A wide variety of storage conditions can be tested, including temperature, cryoprotectants, and...
STABILITY TESTING AND STORAGE
With a nationwide network of 29 environmental laboratories, 3 life sciences labs, 2 LabOps locations, and 46 service centers, Pace Analytical offers compendia (USP, EP, JP) methods of analytical services for qualitative and quantitative assessment of raw materials,...
Our leading competence centers provide a variety of services, including stability testing and the creation of stability reports, storage, and optimizing production methods. We plan studies designed according to ICH guidelines1.
R&D AND STABILITY SERVICES
Sterin conducts stability studies on parenteral clinical drug products in monitored chambers with conditions like 40°C/75% RH, 30°C/65% RH, 25°C/60% RH, 5°C, -20°C & Photostability. Its on-site & configurable reach-in chambers are validated & alarmed.
Raw material, intermediate testing, finished product testing, stability testing and validation testing laboratory.
In addition to traditional shelf-life stability studies, Cambrex routinely performs specialized studies such as freeze/thaw, compatibility, & photo stability studies. Our analytical experts can support your stability testing at all phases of development.
STABILITY STUDIES ANALYSIS
Chromcore analytical services include stability study services such as stability testing (developmental, registration, commercial & market extension stability studies) along with photostability studies.
We are equipped with dedicated facilities to perform full stability studies, according to the latest ICH and FDA recommendations, and following the requirements for Climatic Zones I, II, III and IV.
ICH STABILITY STUDIES OF ACTIVE SUBSTANC...
In the analytical development area, LABIANA GROUP offers a wide range of services for pharmaceutical and veterinary industries and provides ICH stability studies of active substances.
ACCELERATED & LONG TERM STABILITY STUDIE...
Aviz Labs, together with specialized partners, is able to assist clients needing stability and testing studies conducted. The results of such testing not only provides customers with the confidence that a quoted lifespan can be realistically achieved.
ANALYTICAL & STABILITY TESTING
Onyx's analytical method development ensures that the methods used to measure purity & potency of small molecule API are of high quality. Its early-phase work consists of the production of robust process outlines, stress testing, impurity tracking, etc.
GBI offers stability studies of cGMP material per ICH guidelines. As part of GBI's services, product specific stability protocols and reports are generated for multiple storage conditions such as long-term (real-time) and accelerated conditions.
Lamda’s analytical options are available on a stand-alone bases or as part of a full development package such as Analytical method development & Validation, Forced degradation studies, Photostability studies, Method transfer, API controls etc
FULL ICH STABILITY CONDITIONS
UPM’s analytical group has a diverse background in analytical method development and in-depth understanding of all facets of the drug development process.
DRUG-SUBSTANCE STABILITY TESTING
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 s...
Our researchers executes every phase of the development process with the utmost care, including identification of reliable suppliers of active ingredients, realization of laboratory and industrial-scale trial batches, development and validation of analytical method...
PHOTOSTABILITY
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
PYRAMID understands the importance of accuracy, integrity, timeliness and compliance for all stability study programs. Our stability services are proven reliable for pilot formulations, clinical batches and marketed products. Our controlled storage area accommodate...
ICH CONDITIONS STABILITY STUDIES
PHOTOSTABILITY OF API
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.
Chromcore's drug product characterization offers photostability testing, determination of appropriate storage conditions, stability of primary packaging for metered-dose inhaler, dry-powder inhaler (DPI), nasal sprays & nebulizers.
COMPARATIVE STABILITY
ICH STABILITY TESTING
Servier CDMO offers a full range of contract development and manufacturing services, from concept and product development to analytical testing, commercial scale and regulatory approval.
PCI features fully audited, in-house laboratories in both our European and North America locations offering a range of analytical services to support clients in the development and commercialization of new medicines.
Cyndea Pharma focuses its efforts on the development and manufacturing of generic drugs with a distinctive complexity, either due to their difficulty to develop pharmaceutically, or due to their handling incompatibility with high activity products.
MATRIX STABILITY EVALUATIONS
FORMULATION EVALUATION STABILITY TESTING
STABILITY-INDICATING METHOD VALIDATION S...
All formulation services can be utilized independently or fully integrated within on-going services at Novick. These services includes Accelerated, Intermediate, Long term Stability Studies, Forced Degradation studies.
Globela Pharma Pvt Ltd has uplifted our existing R & D facility, and installed fully functioning in house R & D center- with state of the art infrastructure, and experienced, skilled manpower.
We inspect and test for all standard climate zones according to the guidelines of the International Conference on Harmonisation (ICH).
CURRENT ICH & CUSTOM CONDITION STABILITY...
Pace Analytical Life Sciences provides ICH and custom storage as well as analytical services for your cGMP stability programs. PLS offers long and short-term (accelerated) stability services for R & D and commercial products, as well as personalized project managem...
CAPSULES FOR STABILITY STUDIES
Colorista® is an optimized tool for formulation development enabling compatibility studies before deciding on the final color for the commercial drug products.
Servier brings 60 years of experience in process development, intermediates, APIs and high-potency APIs. Our full cGMP?/?FDA-approved chemistry network includes R&D, production and supply chain expertise with full regulatory support.
STABILITY STUDY DEVELOPMENT ACCORDING TO...
Jubilant HollisterStier’s innovative microbiological and analytical labs are operated by experienced professionals using the most current equipment and procedures to ensure seamless technical transfer of analytical methods for our clients.
Biolink Life Sciences offers a full range of services including stability studies, custom synthesis, process development, analytical method development & validation, reference standard synthesis, pre-formulation & formulation development services.
QC TESTING & STABILITY MONITORING
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.
CUSTOM STABILITY STUDIES
Lubrizol Life Science Health pharmaceutical stability programs operate under ICH guidelines, supplemented by custom programs that are designed as needed
Stability studies are performed both on API and finished products in various packaging and climatic conditions. Development, regulatory and on-going stability studies are managed in accordance with european and us FDA recommendations.
PHOTOSTABILITY ANALYSIS
Our services include Development of stability indicating methods, photostability, accelerated and long-term stability programs.
AGING STUDIES
Pace Analytical Life Sciences (PLS) is a full-service contract testing laboratory providing physical and functional testing services to the pharmaceutical and medical device industries.
AvacaPharma's scientific team has an up to date understanding of product development aspects. Analytical scientists focuses on method development, validation, instrumentation, technology transfer and stability studies.
FORCED DEGRADATION STUDIES & STRESS TEST...
At CARBOGEN AMCIS AG, we can perform forced degradation tests, stress tests, and stability studies according to the International Conference on Harmonisation (ICH) guidelines.
STATIC DECAY TESTING
DEV. & EVALUATION OF STABILITY INDICATIN...
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.
Stability studies (storage and testing) are performed as per ICH QrA and photo stability testing as per ICH QtB.
LONG-TERM STABILITY TESTING
INTERMEDIATE STABILITY TESTING
CONTROLLED DRUG PRODUCTS STABILITY TESTI...
Stability studies for drug substances and drug products according to ICH requirements; performed in our own qualified stability chambers, compatibility studies of binary or complex mixtures of API(s) with excipient(s) performed to Support early development phases.
COMMERCIAL PRODUCT STABILITY TESTING
COMPARATOR STABILITY TESTING
Our R&D services include Drug substance, clinical trial materials, IND, NDA & ANDA registration stability testing, All ICH climatic stability zones, Photostability chamber, Forced degradation studies, Computerized data management & pull schedules, etc
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.
ASSIGNMENT OF SHELF LIFE
POST APPROVAL STABILITY
PHOTO-STABILITY
Stability-indicating assay and/or related substances methods for drug substances & products (stress stability testing as per ICH).
STABILITY PROTOCOL DEVELOPMENT & PROGRAM...
GVK BIO offers a broad range of analytical services for complex research needs. We perform method development, validate and transfer Good Manufacturing Practice (cGMP) compliant methods for a broad spectrum of pharma compounds.
STABILITY STORAGE, TESTING & DATA TRENDI...
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
STRESS TESTING STUDIES
Forced degradation is a degradation of new drug substance and product at conditions more severe than accelerated conditions. It is required to demonstrate specificity of stability indicating methods and also provides an insight into degradation pathways.
CEBIPHAR provides its support from the study design up to analyses: protocol design and optimization, sophisticated ICH storage platform regulatory compliance, multi-disciplinary teams: physico-chemical, pharmaco-technical, and microbiological analyses.