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CAPACITY CAPABILITIES CONTROL LIFE INSPIRED, QUALITY DRIVEN LIFE SCIENCES STABILITY SERVICES
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LIFE SCIENCES STABILITY SERVICES - SGS...2 From study design, storage and shelf-life stability to monitoring, analytical testing and documentation, SGS offers a complete range of comprehensive

Aug 05, 2020

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Page 1: LIFE SCIENCES STABILITY SERVICES - SGS...2 From study design, storage and shelf-life stability to monitoring, analytical testing and documentation, SGS offers a complete range of comprehensive

CAPACITY

CAPABILITIES

CONTROL

LIFE INSPIRED, QUALITY DRIVEN

LIFE SCIENCES

STABILITYSERVICES

Page 2: LIFE SCIENCES STABILITY SERVICES - SGS...2 From study design, storage and shelf-life stability to monitoring, analytical testing and documentation, SGS offers a complete range of comprehensive

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From study design, storage and shelf-life stability to monitoring, analytical testing and documentation, SGS offers a complete range of comprehensive stability testing services to help you improve efficiencies and reduce costs. With more than 25 years of experience and over 100,000 samples currently on storage, our life science laboratories located around the globe have the skills and capacity to handle any pharmaceutical and biologic stability projects.

THE CAPABILITIES ARE LIMITLESS

SGS LIFE SCIENCES

SGS Life Sciences enables the medical and health innovators of the world to deliver life-changing solutions in the quickest, safest and most efficient way, helping improve the lives of many, by providing the highest quality services, reliable expertise and guidance through our network of labs conveniently located around the globe.

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GET TO MARKET QUICKLY, SAFELY & EFFICIENTLY

RELIABLE & ACCURATE RESULTS

When it comes to the pursuit of developing life-changing solutions, there’s no such thing as one size fits all; our studies are engineered to your unique needs. As a fully accredited, professionally recognized organization, you can rely on us to act as a neutral third party CRO and deliver unbiased results. We guarantee reliable and accurate testing using state-of-the-art facilities, equipment and techniques.

QUALITY & COMPLIANCE

Pushing the boundaries of innovation can be challenging. Identifying, analyzing and mitigating compliance risks are essential in developing an effective compliance program. With more than 40 years of experience, SGS is a trusted name with a history of excellence in meeting regulatory compliance and bringing projects to market. We have a reputation for clinical & laboratory quality & operational excellence (Harmonized QMS and Validation & Transfer methods, LIMS, Lean).

EXPERT GUIDANCE

Reduce costs and improve profits by bringing your products to market quickly and safely; let our experienced consulting and project management teams develop a market access strategy with specific tools and tactics to plan, implement, and monitor your stakeholder engagement activities while reducing errors and potentially costly mistakes that can delay bringing your product to market.

SCALABILITY & GROWTH

SGS is a trusted global drug development partner; our conveniently located network of labs offer a flexible range of integrated services and expertise, providing you with the knowledge and ability to scale.

• Wide-range of laboratories and clinical research infrastructure

• Size and diverse testing capabilities matching Biopharmaceutical and Small molecules needs

• International network across America, Europe and Asia

We provide services along the entire drug development pathway. With over 40 years of experience as a global contract service organization, SGS provides integrated solutions from preclinical activities to Phase I-IV trials, bioanalytical, R&D, characterization, biosafety, and quality control testing of small and large molecules, raw material products and containers.

WHY TEST WITH SGS LIFE SCIENCES?

DISEASE

DISCOVERY

PRECLINICAL

CLINICAL

ROUTINE PRODUCTION

MARKET

CURING

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OUR GUIDING PRINCIPLESAt SGS, we are guided in all that we do by the values of trust, quality, expertise, reliability, global partnership and integrity; these are the bedrock upon which our organization is built. We also believe that while we are in the business of life sciences, our commitment lies equally in life-saving. This mean taking responsibility for our own operations and practices to ensure we are protecting and preserving all life, in its many forms:

PEOPLE ANIMALS PLANET

We do not test on weapons or anything that could be used to threaten life.

As a cruelty-free organization, we do not conduct any tests on animals.

We are an award-winning leader in sustainability and carbon neutral organization.

INDUSTRY GROUP LEADER IN DOW JONES SUSTAINABILITY INDEX

• RobecoSAM Gold Class sustainability award winner 4 years in a row

• Ecovadis Gold Rating Sustainability Performance 3 years in a row

• RobecoSAM Industry Mover

• CDP Climate A List

• 356+ community projects

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EXCELLENCE & EXPERIENCESGS enables the medical and health innovators of the world to deliver life-changing solutions in the quickest, safest and most efficient way, helping improve the lives of many. We provide the highest quality services, reliable expertise and guidance through our network of labs conveniently located around the globe.

STRATEGIC PARTNERSHIPAnalytical testing is a long-term project. You need a strategic partner rather than a short-term service provider; having built a strong reputation based on trust and integrity, many companies choose to use SGS integrated services to help them reduce their number of vendors, streamline processes, and improve efficiency. We offer a full range of analytical testing services across all phases of product development and flexibility to work within your reporting and invoicing systems.

RESOURCE MANAGEMENTEmploying an experienced and dedicated team for your project enables you to accommodate changes in the project related to the scope of work, priorities, and project timelines. Moreover, our Full Time Equivalent (FTE) services ensure high efficiency and quick turnaround time while allowing you to focus on your core competencies. This provides cost savings by allowing you to avoid building specialized facilities, hiring staff, etc.

VIRTUAL & REAL EXPERIMENTATIONWe can reduce the risk of downstream failures by performing early-stage virtual testing to drive development of better formulations that will pass wet lab stability tests. This enables researchers to accelerate the innovation cycle by learning from past trends and patterns in stability data, enabling a design approach that mitigates potential stability issues in the design stage of discovery.

THE SGS ADVANTAGE

ABOUT SGS

SGS is the world’s leading inspection, verification, testing and certification company. We are recognized as the global benchmark for quality and integrity. With more than 95,000 employees, we operate a network of more than 2,400 offices and laboratories around the world.

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WE PROVIDE YOU WITH:

• Support in Designing Studies for Real-Time, Stress and Photostability

• Development and Validation of Stability Indicating Methods

• Storage and Management of Stability Samples

• Examination of Stability-Relevant Parameters

• Interim Reports for Every Testing Period

• Comprehensive Final Report

LONG-TERM, INTERMEDIATE AND ACCELERATED STORAGE

Long-term, intermediate and accelerated storage includes:

• 25°C / 40% r.h.

• 25°C / 60% r.h.

• 30°C / 65% r.h.

• 30°C / 70% r.h.

• 30°C / 75% r.h

• 40°C / 75% r.h

• 40°C / not more than (NMT) 25% r.h

• +5°C

• -20°C

• -80°C

• Photostability

• Customer-Specific Conditions

• Transport Stability (Freeze and Thaw, Cycle Test)

• In-use stability

CLIMATIC ZONES

We offer the following climatic zones (according to ICH):

• 21°C / 45% r.h.

• 25°C / 60% r.h.

• 30°C / 35% r.h.

• 30°C / 70% r.h.

SERVICES

Page 7: LIFE SCIENCES STABILITY SERVICES - SGS...2 From study design, storage and shelf-life stability to monitoring, analytical testing and documentation, SGS offers a complete range of comprehensive

CANADA

• Toronto (Markham, ON)

+1 905 305 0998

[email protected]

• Toronto (Mississauga, ON)

+1 905 364 3757

[email protected]

USA

• Chicago (Lincolnshire, IL)

+1 847 821 8900

[email protected]

• New York City (Fairfield, NJ)

+1 973 244 2435

[email protected]

• Philadelphia (West Chester, PA)

+1 610 696 8210

[email protected]

EUROPE ASIAAMERICAS

CHINA

• Shanghai

+86 21 6115 2197

[email protected]

INDIA

• Chennai

+91 44 6462 9711

[email protected]

• Mumbai

+91 22 6457 2540-45

[email protected]

FIND US HERE

BELGIUM

• Brussels (Wavre)

+32 10 42 11 11

[email protected]

• Brussels (Zellik)

+32 22 15 04 01

[email protected]

FRANCE

• Paris

+33 1 41 06 95 93

[email protected]

• Poitiers

+33 5 49 57 04 04

[email protected]

GERMANY

• Berlin

+49 30 3460 7500

[email protected]

• Frankfurt (Taunusstein)

+49 6128 744 245

[email protected]

• Frankfurt (Wiesbaden)

+49 611 962 5910

[email protected]

GREECE

• Athens

+302 105 720 777

[email protected]

ITALY

• Florence

+39 0586 852591

[email protected].

SWITZERLAND

• Geneva

+41 22 794 83 74

[email protected]

UK

• Glasgow

+44 141 952 0022

[email protected]

Page 8: LIFE SCIENCES STABILITY SERVICES - SGS...2 From study design, storage and shelf-life stability to monitoring, analytical testing and documentation, SGS offers a complete range of comprehensive

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