Biologics Characterization Services
Product Description
SGS North America Inc.
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US -
2015On CPHI since
Categories
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 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... -
Product Biometrics Services
Data management/statistics and medical writing
As one of the largest independent data management teams in Europe, SGS supports all in-house and external project needs for clients’ clinical trials, powered with Clinitrial®, Oracle Clinical® and SAS®. Clients benefit from a knowledgeable, proactiv... -
Product Environmental Monitoring
In addition to acceptance tests for the installation of clean rooms in production facilities, SGS can perform routine monitoring of viable and nonviable contamination of production facilities. SGS offers a broad range of monitoring services for clean rooms and can also provide you with customized hygienemo... -
Product Regulatory & Medical Affairs
The Regulatory Affairs department at SGS offers consulting in both European and U.S. registration of Biotech and, Prescription drugs, veterinary products and medical devices with comprehensive EMEA and FDA authorities expertise. SGS has established strategic submission plans using extensive country specifi... -
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 Method Development & Validation
SGS life science laboratories have extensive knowledge and expertise in developing and validating methods for raw materials, API’s, finished products and cleaning validation.
SGS offers development and documentation of analytical protocols and reports for proprietary and nonproprietary test met...
SGS North America Inc. resources (2)
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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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