Regulatory & Medical Affairs

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...

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...

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...

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...

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...

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...

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...

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...

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.

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...

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...

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...

The CRO will undertake this clinical trial at multiple sites worldwide, starting at the AZ Sint Maarten hospital in Mechelen, Belgium.

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).

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.

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.

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.

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.

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.

Genetic stability and identity testing are key requirements for regulatory approval of therapeutic biological products produced using a cell bank system.

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.

Our experts provide effective and efficient testing solutions for analytical development, biologics characterization, biosafety and quality control, as well as clinical research services.