Method Development & Validation
Product Description
SGS North America Inc.
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US -
2015On CPHI since
SGS North America Inc.
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US
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2015On CPHI since
More Products from SGS North America Inc. (15)
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Product Biologics Characterization Services
As a pioneer of physicochemical characterization, we offer you unrivaled expertise in protein analysis. Our laboratories helped to develop mass spectrometry (MS) mapping of biotechnology products, together with other mass spectrometry strategies related to protein/glycoprotein analysis, which have become s... -
Product Extractables & Leachables Testing
The assessment of Extractables and Leachables in bio/pharmaceutical products is an important step in drug product development. Processing equipment, as well as, primary and secondary container closures are potential vectors for chemical contaminants. Monomers and polymer additives such as antioxidants, pla... -
Product Quality Control Testing
Analytical chemistry services from SGS provide you with the bio/pharmaceutical expertise and regulatory qualifications to perform the necessary raw material testing, and testing on APIs, finished products, packaging material and medical devices. -
Product Analytical Chemistry
SGS provides the professional expertise and regulatory qualifications necessary to perform analytical testing of raw materials, APIs, finished products, packaging material and medical devices. Well-equipped state-of-the-art laboratories offer comprehensive testing services according to the pharmacopoei... -
Product Biologics Characterization
SGS’ range of services dedicated to biopharmaceutical product characterization bring the most recent developments in testing technology to companies across the globe. In 2010, SGS acquired the M-Scan Group, the world leaders in the application of advanced mass spectrometry
techniques for protein and c... -
Product Microbiological Testing
SGS is a leader in Microbiology Quality Control testing, providing a complete array of services for the bio/pharmaceutical industry. SGS’ scientists are published and active on the scientific committees of several organizations. Capabilities range from assessment of microbial contamination to confirmat... -
Product Biosafety Testing
In 2012, SGS acquired Vitrology in order to provide a comprehensive range of biosafety services for biologics, including: virology, cell and molecular biology as well as microbiology and electron microscopy. Health Authorities, including the US FDA and the EMA, require biopharmaceuticals to undergo safety ... -
Product Stability Studies
From study design to storage, monitoring, analytical testing and documentation, SGS offers services to your complete satisfaction. With more than 25 years of experience and currently more than 100,000 samples in storage, SGS has the skills and the capacity to handle your stability projects. SGS can provide... -
Product Bioanalytical Testing
As a leading bioanalytical service provider, with GLP/GMP compliant laboratories, we are able to serve pharmaceutical and biopharmaceutical companies of all sizes with a range of tests for drug development at both pre- clinical and clinical stages – from early to late phase. We also develop assays (includi... -
Product Package and Container Testing
SGS is an industry leader in Package and Container Testing (USP, EP, JP, BP), providing full packaging testing for the drug industry. The safety and efficacy of any pharmaceutical product is inextricably linked to its packaging. Containers or closures that do not meet the physical, chemical, or biologi... -
Product Clinical Pharmacology Services
As one of the largest European Early Development CRO, SGS offers a complete range of Clinical Pharmacology services encompassing:
- First In Human trials: Single Ascending Dose (SAD) & Multiple Ascending Dose (MAD), combined protocols: SAD/MAD + food + POC
- Regulatory Phase I trials: D... -
Product Phase II-IV Clinical Trial Management
Employing a team of highly trained experts in the latest International guidelines and company SOPs, SGS has conducted over 800 projects including trials with patients in Western, Eastern and Central Europe, Russia, and North America. SGS’ monitoring and management offices are located in the USA, Fran...
SGS North America Inc. resources (10)
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News SGS joins with Biophytis to launch international trial of COVID-19 related respiratory failure treatment
The CRO will undertake this clinical trial at multiple sites worldwide, starting at the AZ Sint Maarten hospital in Mechelen, Belgium. -
Brochure Bioanalysis Testing Solutions
With over 30 years of experience and operating out of our GLP/GCP compliant laboratories. SGS has the expertise to both develop assays from scratch (including LC-MS/MS, immunoassays and cell-based assays) and to support large scale routine sample analyses, from regulatory pre-clinical (toxicology) to early and late clinical studies (Phase I to IV).
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Brochure Biologics Testing Services
A full package of Biologics testing services to cGMP standards from early phase characterisation including Biosafety to Quality Control release testing enabling you to outsource your biologics.
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Brochure Extractables & Leachables Testing Services
Extractables & leachables studies enable drug sponsors to quantify and identify the risks of potentially toxic leachable impurities migrating into a drug solution from container closure systems, processing equipment or packaging.
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Brochure Biosafety Testing Services
Life-saving medicines are heavily regulated during development, manufacture and distribution. To fulfill regulatory requirements, the biopharmaceutical industry is increasingly looking for independent service providers who can deliver comprehensive characterization solutions on one site. SGS’s global center of excellence for cell bank characterization & virus testing is located in the United Kingdom and provides services with ultimate reliability, highest GLP/cGMP quality and scientific expertise.
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Whitepaper DETECTION OF MYCOPLASMA IN BIOPHARMACEUTICALS VACCINES AND GENE CELL THERAPIES
Mycoplasma are a form of bacteria that are characterized by the absence of a cell wall surrounding the cell membrane. This renders them inert to many familiar antibiotics, including the beta-lactams, whose activity relies on cell wall disruption. Many different mycoplasma are pathogenic in humans, and they are also commonly found as contaminants in cell cultures. Although the contamination does not create turbidity, factors such as cell line growth rates and viral vaccine production can be adversely affected. This clearly poses a problem for processes that involve cell culture, and thus, being able to detect them is important.
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Whitepaper EXTRACTABLES AND LEACHABLES: DETERMINING RISK IN SINGLE-USE SYSTEMS FOR THE BIOLOGICS INDUSTRY
Single-use systems (SUS) are increasingly becoming the norm in biologics development and manufacturing. Around 85% of the pre-commercial biopharmaceutical sector uses SUS and it is increasingly being adopted for commercial manufacturing. SUS have significant advantages but are not without drawbacks. A 2018 survey showed that 73.3% of biologics insiders listed contamination from extractables and leachables to be a major problem.
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Whitepaper Cell substrate Characterization - Genetic Stability and Identity Testing at SGS
Genetic stability and identity testing are key requirements for regulatory approval of therapeutic biological products produced using a cell bank system.
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Whitepaper COMPLEX GENERIC APIS: A PRIMER
The potential for economic reward associated with the development of complex generic medicines means there has been dramatic growth in the sector in recent years. However, opportunity is not without complexity. Unlike other medicinal products, manufacturers of complex generics cannot rely on textbook characterization or QC testing to prove compliance with regulations.
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Brochure SGS Life Sciences Drug Development Services
Our experts provide effective and efficient testing solutions for analytical development, biologics characterization, biosafety and quality control, as well as clinical research services.
Frequently Viewed Together
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Product Biologic drug substance CDMO services
From pre-clinical development to commercial supply, Patheon by Thermo Fisher Scientific is an industry leader in the development and manufacture of mammalian cell culture drug substances. Patheon offers biotech and pharmaceutical companies the ability to pursue opportunities around the globe with a fully i...
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Product Analytical Services
Pharmaffiliates is providing all the Analytical Services (i.e. Method Development, Method Validation & Transfer, Stability Studies, Contract Analysis, etc)
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Product Biotherapeutics
To accelerate the development and marketing of your Biotherapeutics, Quality Assistance offers a complete analytical package to meet the EMA and FDA requirements, all on one site.
Whether it is to extend your analytical capacities or to outsource parts or all of your analytical needs, ...
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Product Consulting: Quality Management System
Quality management systems (QMS) are crucial for the success of any business. They provide an accurate way to track and measure quality across all areas of your company. One key benefit of a quality management system is that it establishes clear goals, roles, and responsibilities. It also tracks the pr...
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Product Analytical services - OEL: 50 ng/m3
• Control of pharma samples solid state : Identification and quantification of solid state, method development and validation, routine QC. • Analytical techniques available : XRPD, DSC, TGA, DVS, Laser PSD, FTIR, IDR. • All analyses are applicable to toxic samples down to : 50 n...
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Product Analytical Services
With a team of experienced scientists and a robust toolbox of analytical techniques and equipment, Experic can support the life cycle of your oral solid dose and/or inhalation pharmaceutical products. Our laboratory staff provides comprehensive analytical solutions to support the formulation, development, ...
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Product Development Sciences
Our development laboratories are well equipped for conducting a diverse range of experiments. These encompass formulation development, cycle design and process refinement, as well as evaluating finished product. Ease of scale-up is accomplished by completing process development studies within a pilot scale...
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Product Core Technologies and Services
• API / GMP Manufacturing • Rapid Process Development, Flawless Upscaling, and Economy of Scale-Production • Simulated-Moving Bed (SMB) Chromatography • Heterocyclic, Hazardous and Malodorous Chemistries • Organometallic and Cryogenic Chemistry • Transition-Metal Catalysis • High-Pressur...
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Product Method Validation
Neotron Pharma is able to validate analytical methods developed internally or transmitted by the customer using top of the range equipment such as:
- HPLC-UV / DAD / MSMS
- GC-FID / ECD / MSMS (even in Headspace)
- ICP-MS / AAS / AES / OES
- Post-column derivatization
- Particle si...
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Product FPFs
• Genexol®PM Inj.(Paclitaxel) • Genexol® Inj.(Paclitaxel) • Nanoxel®M Inj.(Docetaxel) • Docetaxel Inj.(Docetaxel) • Nexatin® Inj.(Oxaliplatin) • Everose® Tab.(Everolimus) • Pemed®S Inj.(Pemetrexed) • Azalid® Inj.(Azacitidine) • Decilid® Inj.(Decitabine) • Lenalid® Inj.(Lenalid...
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Product Biosimilars Portfolio
• Pegfilgrastim (Filed with EMA) • Filgrastim (Filed with EMA) • Trastuzumab (Filed with EMA, MHRA, Received recommendation for marketing authorization in India) • Bevacizumab (Filed with MHRA) • Omalizumab (Global PhIII ongoing) • Denosumab (Global PhIII ongoing) • Ranibizumab (Global PhIII ongoing...
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Product Formulation Development
Recipharm offer formulation development services for all dosage forms. We develop everything from simple formulations for early studies to more complex formulations suited for commercialisation.
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Product Development
Synerlab provides wide range of services which includes development. Contact us for more information.
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Product Complex drug formulation
We like to get involved right from the start of a development project and work closely together with our clients and partners on transforming the idea into a product with a solid and commercially viable target product profile (TPP). We set the bar high but always work step by step with a clear focus on...
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Product Analytical Services
Actylis performs routine and non-routine analytical testing for various industries, in support of manufacturing processes, QA/QC functions, R&D projects, and environmental applications. Leveraging state-of-the-art instrumentation, extensive knowledge base, as well as internal, cross-functional competen...
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Product GPX1500 Film Pharma
The Gasporox GPX1500 Film Pharma represents a new approach to headspace oxygen gas inspection – fast, accurate, non-intrusive and non-destructive, in IV-bags and pharmaceutical pouches.
The GPX1500 Film Pharma is a very compact and easy to use instrument to measure accurate the headspace of phar...
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Product Clinical Trials and Bioequivalence Studies, Clinical Services, Bioanalysis
ACDIMA BioCenter is a comprehensive clinical CRO based in Jordan and founded in 2000. ACDIMA BioCenter is a multinational investment operates as business-driven model with focus on supporting the industry of clinical trials and bioequivalence studies services that help expediting their regulatory a...
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Product Analytical Testing and Formulation Development
Quality Chemical Laboratories is known for its capabilities in the development and validation of analytical methods for raw materials, drug substances, and drug products. With a strong focus on quality and precision, QCL employs cutting-edge technologies and a highly skilled team of scientists to offer com...
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Product GALENIC DEVELOPMENT
TECNALIA, experts in Pharmaceutical Development, Scale-up & Pilot Batches Manufacturing, Clinical Trials and Contract Manufacturing
GALENIC DEVELOPMENT
• Preformulation studies.
• Design and galenic develop...
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Product Method Development
We are specialist in the method development of analytical methods for analysis of API, Final Drug Products or low level impurities. Usually followed by full validation in accordance to ICH guidelines.
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Product Laboratory Services
Laboratory Services
Our 30 years of experience and our continual quest for improvement ensure we deliver analytical services of the highest level for active ingredients, excipients, medicinal products and drug-related products. In addition to developing and validating analytical methods, batch-...
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Product PHARMACEUTICAL ANALYSIS DEPARTMENT
Spark-Lab Pharmaceutical Analysis Department performs routine analyses with a special emphasis on determination of excipients, such as:
• Quantitative determination of sorbitol, glycerol, maltitol, mannitol in liquid forms based on our own method; • Quantitative determination of glucos...
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Product Analytical services
Analytical services
In addition to the basic product quality control, the following connected services are offered, which are required throughout the product development or before the market launch of the respective products:
GMP for excipients, risk assessment...
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Product MODDE® | Explore. Improve. Advance!
MODDE® offers Design of Experiments Software that Accelerates Progress.
Design of Experiments (DOE) is the fastest and most cost-efficient way to design effective experiments, increase productivity, and tackle your toughest challenges in development and manufacturing. With MODDE®&n...
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Product Analytical Services - Inhaled Products
With extensive, state-of-the-art analytical testing facilities and equipment, our expert teams are able to develop and validate the methodologies required to characterise inhaled delivery platforms, especially DPI, pMDI and nebulised products.
To ensure seamless support for your development...
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Product Analytical Services
With 55+ years of experience, our expert teams develop 1,000+ analytical methods and validate 250+ methods annually. Drawing upon an extensive range of analytical technology, combined with a wealth of analytical knowledge, we can add real value to your drug development and commercialisation programs....
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Product Analytical package
XEDEV provides a broad range of analytical tools including : • Solid state analysis: mDSC, XRPD, PLM, TGA, FTIR, RAMAN • Powder characterisation : SEM, PSD (both wet and dry), flowability • Tablet characterisation : friability, disintegration, hardness, dissolution • Residual solvent determination :...
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Product Analytical Services & EU Batch Certification
Method Development and validation
Stability Studies
European testing & batch certification
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Product Analytical Services
ChemCon’s analytics team takes care of your inquiries if you are looking for ICH-compliant quality control, GMP validation, release analysis, impurity determination, reference standards or answers to other analytical queries. Close, outcome-oriented communication is the key to a successful partnership:...
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Product Kemwell Biopharma
SERVICES Kemwell provides integrated development and manufacturing services for companies that require one-stop solution for mammalian cell-culture based protein therapeutics The team is experienced to undertake end-to-end activities right from cell line development till cGMP clinical and commercial manufa...
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Product Pharmaceutical powder and particle morphology
Intertek offers wide range of pharmaceutical services which includes pharmaceutical powder and particle morphology. It belongs to pharmaceutical analysis services category. It includes dry powder analysis: physical characterisation, particle morphology using malvern morphologi g3, particle size analysis – ...
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Product Microbiological Analysis
Oasis Test House caters to the microbiological requirements for its clients serving them with the below analysis. • Preservative Efficacy Analysis • Sterility Test • Sterility Validation • Microbial Limit Test Validation • Microbial count and pathogens • Bioburden testing • Antibiotics assay • Vitam...
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Product QACS Pharmaceutical services
QACS Lab is GMP/GLP certified and provides contract laboratory testing for Pharmaceuticals. Methodologies stay in accordance with EMA & FDA. QACS is equipped with Microbiological - Chemical - Molecular - Packaging laboratory premises to provide variety of Pharmaceutical testing solutions &...
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Product Wasdell Laboratory Services
By the end of 2017 we will have a MHRA, GMP licenced laboratory. We will be offering a wide range of services for routine Quality Control analysis including QC release testing, method validation and stability analysis (analytical and microbiological). We work to the highest standards of GMP and GLP with r...
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Product Analytical Services
Physico-Chemical testing
- General identification (TLC, HPLC)
- Assay (UV/VIS, HPLC-UV, GC-FID, LC-MS/MS) and dosage uniformity
- Related substances identification and quantification (HPLC-UV, GC-FID, LC-MS/MS)
- Physical determinations (pH, viscosity, density)
- Moisture...
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Product Facility & Process Validation Testing
Manufacturing facilities and processes can be a primary source of product contamination. Nelson Labs offers a range of services to assess these manufacturing environmental conditions, in addition to water system validations, raw material screening and residual manufacturing material tests.
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Product Analytical method development
MJR PharmJet uses its long gained experience on nano and microparticle formulations to meet your method development needs. We are specialized on the method development of particulate formulations for solid, semi solid and liquid formulations.
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Product Quality Control Testing
Bringing a compound from the laboratory to the market is a long and winding road with a great number of scientific, safety and regulatory challenges. SGS has been offering high quality analytical testing and clinical research services to support drug research, registration and production.
SGS leve...
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Product Analytical Services
Solvias provides cGMP-compliant contract analytical services to help you ultimately provide safer products to consumers. We provide a comprehensive range of analytical services to the pharmaceutical, biotech, medical devices and cosmetics industry with similar regulatory requirements for raw materia...
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Product Method Development, Optimization, and Validation Services
At Integrated Analytical Laboratories (IAL), our approach to method development helps reduce bottlenecks and reduces errors. We understand time is of the essence, so IAL provides a consultative approach with our partners to ensure that your new drug product will meet the goals and objectives you a...
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Product Analytical Services
Solvias provides cGMP-compliant contract analytical services to help you ultimately provide safer products to consumers. We provide a comprehensive range of analytical services to the pharmaceutical, biotech, medical devices and cosmetics industry with similar regulatory requirements for raw materials, int...
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Product Analytical Development and expertise
Our analytical experienced team support the pharmaceutical development during every phase of the development process. Analytical development transfer and validation, characterization capabilities, stability analysis, ICH Q3D (residuals solvent risk assesment), ICHQ3C (elemental impurities risk assesment...
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Product Analytical Development
Idifarma’s analytical development services include the following activities:
- Solubility studies in different media (organic, aqueous and different PH levels).
- Characterization of the thermal profile and identification of polymorphic forms by DSC.
- Impurities profile characterization. q...
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Product Analytical Services & Methods
CritiTech provides a suite of material characterization and analytical services to support our clients drug development projects from proof-of-concept through cGMP production. Our testing data and documentation is reviewed by experienced technical and quality staff to ensure it can be used to support regul...
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Product GC 456 System
SCION 456 GC Gas Chromatograph When your requirements demand more functionality or you want room to upgrade, the SCION 456 easily meets your need. Supporting three injector and four detector positions (including the mass spectrometer) with full independent access, no other gas chromatograph system pr...
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Product HPLC Columns by VDS OPTILAB
HPLC columns from VDS optilab have been impressed customers from all areas of analytics, ranging from universities and government agencies to small and medium-sized companies and large companies in the chemical and pharmaceutical industries. Benefit from the advantages of the VDSpher phases product fa...
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Product Ghost-Buster
Welch Ghost-Buster column can efficiently adsorb and remove the impurities from the mobile phase to eliminate their interference to the target peaks.
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