Quality medicines, from molecule to market

The mission of SGS Life Science Services is to safeguard the quality of medicines by providing professional clinical research, analytical development and quality control testing of pharmaceuticals, biologics and medical devices. This creates value for its clients and provides benefits for patients.

SGS has 35 years' experience as a global contract service organisation providing integrated solutions, from preclinical activities to phase I-IV trials, bioanalysis, analytical development and quality control testing. With the recent acquisition of M-Scan in November 2010, SGS enhanced its service portfolio for the characterisation of biologics with GLP/GMP contract analytical services, consultancy and training based on highend mass spectrometry and chromatography.

With 1,200 employees, state-of-the-art clinical pharmacology units and the world's largest network of GMP-compliant laboratories, SGS serves the pharmaceutical, biotechnology and medical device industries across Europe, the Americas and Asia with 25 facilities in 14 countries. Thanks to its global presence and broad range of services, SGS is often a preferred partner of the top 20 pharmaceuticals and biotechnology companies.

Biologics and vaccines
SGS has R&D Centres of Excellence specialising in the analyses of biopharmaceuticals including peptides, proteins, vaccines and glycoproteins such as monoclonal antibodies at all stages of development. The analysis of biopharmaceuticals requires different skills from those of small chemical entities.

Many analytical techniques, such as LC/MS/MS, and capillary electrophoresis or RT-PCR, have emerged from an R&D setting into routine operation. SGS's fully integrated, specialised services from molecule to market have the following advantages:

• lead qualification and optimisation
• molecule characterisation to FDA/ICH guidelines
• regulatory intelligence along the drug development process
• a global view with customised local services delivered by an extensive laboratory network
• a harmonised lab network allowing for method transfer across sites
• best-in-class biologics characterisation. Laboratory services

SGS offers a comprehensive range of life science services.

Operating a global network of 17 laboratories in 11 countries, SGS's Lab Services team provides regulatory-compliant (cGMP/ GLP and/or ISO) analytical services. All laboratories have been inspected by local regulatory authorities and, where applicable, the US FDA or EMA. SGS's QC and bioanalysis services include:

• a harmonised network of analytical labs and consultancy in major markets
• quality-control testing as the company's core competence
• analyses that comply with cGMP, GLP, ISO 17025 and ISO 9001
• comprehensive breadth and depth of tests performed in one source
• leading European CRO in bioanalysis, featuring mass spectrometry and immunoassays
• industry-leading turnaround times.

Clinical research services
SGS is one of Europe's largest first-in-human pharmacology centres, including two phase I units (in Paris and Antwerp), with a combined total of 172 beds. With seven trial management offices covering Europe and the Americas, SGS has the expertise to develop and deliver complex trials supporting screening or large-scale trials and analysis, from phase I to IV. Benefits of SGS's clinical development department include:

• European leader in exploratory and pharmacology trials
• global expert in clinical trial management, focusing on infectious diseases, gastroesophageal disease, CNS and cardiology
• strong biometrics team pioneering the use of EDC systems, which are CDISC-compliant
• regulatory affairs and pharmacovigilance.

With innovative study designs, an R&D Centre of Excellence, optimal facilities and strong regulatory intelligence, SGS can significantly help its clients to ensure the quality, safety and effectiveness of drugs, make the right 'go-no-go' decisions and reduce a product's time to market.

Company profile

SGS Life Science Services

For further information, visit: www.sgs.com/lifescience