Regulatory & Medical Affairs

Regulatory & Medical Affairs
Product Description

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 specific regulatory intelligence covering 76 countries.

The Medical Affairs department at SGS provides full Phase I-IV pharmacovigilance services including Serious Adverse Event (SAE) handling, ADR reports, medical review and narrative medical writing, electronic reporting in Europe to Eudravigilance and Health Authorities.

Read more Show less

SGS North America Inc.

  • US
  • 2015
    On CPHI since
View company profile
Sales Markets
Show more Show less

SGS North America Inc.

  • US
  • 2015
    On CPHI since
View company profile

More Products from SGS North America Inc. (15)

  • Bioanalytical Testing

    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...
  • Package and Container Testing

    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...
  • Clinical Pharmacology Services

    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...
  • Phase II-IV Clinical Trial Management

    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...
  • Biometrics Services

    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...
  • Environmental Monitoring

    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...
  • Biologics Characterization Services

    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...
  • Extractables & Leachables Testing

    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...
  • Quality Control Testing

    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.
  • Analytical Chemistry

    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...
  • Biologics Characterization

    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...
  • Microbiological Testing

    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...
show all 15 other products

SGS North America Inc. resources (2)