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EXPERTS ATYOUR SIDEOver twenty-five years of experience

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About usSYNLAB Pharma provides laboratory services for our clients in the pharma-ceutical, biotechnology and cosmetics industries as well as for manufactur-ers of medical devices and functional foods. Our broad portfolio offers ana-lytical methods for clinical and preclini-cal studies as well as for quality control from a single source.

We support you from drug discovery to release of the final product and offer you a global logistics network.

All services are monitored to the highest standards. Depending on the requirements we work according to: GLP, GCLP, GCP, GMP, DIN EN ISO/IEC 17025/15189.

Take advantage of our extensive experience from more than 3,000 clinical studies and projects.

From our 6 pharma lab locations in the heart of Europe, we offer you worldwide solutions in high and reliable quality. Through our vast network of specialized laboratories, we can offer you all services from a single source, even for complex requirements.

As part of the SYNLAB Group, we are a member of a worldwide network that is present in more than 40 countries on four continents and holds leading positions in most markets. SYNLAB offers a full range of innovative and reliable medical diagnostics for patients, practicing doctors, clinics and the pharmaceutical industry.

Over 20,000 employees contributeevery day to the Group’s successacross different geographies. SYNLAB carries out about 450 million laboratory tests per year, achieving sales revenue of about € 2 billion.

Europe’s largest laboratory service provider.

Aachen

Birsfelden

Linz

Markkleeberg

Berlin

München

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What we offer

Foods for Special Medical

Purposes (FSMPs)SYNLAB Pharma is the GLP, GMP

and GCP lab expert during R&D and manufacturing of functional foods in accordance with the European guideline (1223/2009). Analytical services include:

bioanalytical testing, hygiene, micro-biology, toxi cology and clinical

trial services.

Central Lab

SYNLAB Pharma is providing Central Lab Services since more than 25 years covering all relevant global

regions incl. China. Lab results are comparable worldwide and

lab report layouts are harmonized for all study sites involved. Our clients benefit

from highly dedicated project management teams and

cost-efficient logistics solutions.

CosmeticsSYNLAB Pharma supports all stages of the production

process of cosmetics. We offer consultancy for analytics and quality control, physico-chemical methods,

stability studies under defined climate conditions, microbiological and in-use

stability tests. Quality controls are performed according to EP,

USP or customer requirements.

Medical DevicesThe development of medical

devices requires specialized lab testing in order to cope with the increasing regula-

tory requirements. SYNLAB Pharma has the expertise in running biocompatibility testing (ISO 10993), leachable & extractable studies, toxicological and microbiological tests of

medical devices for biological evaluation in development, registration and

production.

BiologicsSYNLAB Pharma develops and

implements strategies for the analysis of therapeutic proteins, Advanced Therapy

Medicinal Products (ATMP) and biosimilars.

The drug production process is supported by our broad experience in running bioassays and

physico-chemical analytics under GMP. Further area of expertise are: PK and PD, biomarkers and immunogenicity testing

including assay development, optimization and validation.

Release & StabiltyAnother core service of SYNLAB

Pharma is stability studies in accor­dance with ICH Q1A(R2), including

consultancy, planning, storage and analysis. SYNLAB Pharma supports all stages of

successful drug approval: Long­term, intermediate and accelerated stability; ongoing and follow­up stability studies,

stress testing (including photo­ stability testing), and compatibility studies.

Technical Regulatory & Regulatory Affairs

Regulatory project design for early and late stage development including consultation of regulatory

agencies (scientific advice & clinical trial applications).

PharmaceuticalsSYNLAB Pharma provides a

wide range of analytical services supporting our customers from drug

discovery through preclinical and clinical studies to release and manufacturing of the

final drug product.

We have over 25 years of experience in supporting the pharmaceutical industry, from

the measurement of single assays to the execution of complex and deman-ding projects across the entire life

cycle of a medicinal product.

Discovery Pre-clinical Development Clinical Development Market Phase

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DRUG PRODUCT / SUBSTANCE

SAFETY/ STRATIFICATION/

EFFICACY

FULL SERVICE FOR CLINICAL

TRIALS

DIAGNOSTICS

Covering the whole lifecycle of your product

Global Central Lab Services: Global Logistics | Supply | Visit Kits| Storage | Project Management | Data Management

Clinical Monitoring: Safety | Efficacy | Therapeutic Drug Monitoring | Patient Stratification | Adverse Events

Analytical Development: Technical Evaluation | Development of New Tests | Validation (EMA/FDA) | Method Transfer from or to Client

Bioanalytics: TK | PK | Metabolites | PD | Immunogenicity | Bioavailability | Bioequivalence | Biomarkers

Genomics: Sequencing | Genotyping | Pharmacogenomics

Regulatory Compliance: Quality Control, Characterization, Release

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GMP Analytical Services for Drug Products and Drug Substances• Release testing according to

Pharmacopeia (EP/USP)

• Stability studies according to ICH guidelines

• Microbiological testing / bio burden

• Leachable & extractable testing

• Heavy metal determination to ICH Q3D

• Method development and validation for assay and impurity testing

• Cell based potency assay and physico-chemi-cal analytics

• Handling of controlled substances

Expertise

Quality Systems• GLP

• GCP

• GMP

• DIN EN ISO/IEC 17025/15189

Clinical Trial Services• 24/7 lab service for early

phase trials

• Safety panels and hematology

• Full analytical spectrum

• Genetics and PCR

• Microbiology and bacteriology

• Histopathology and cytology

Manufacturing Support Service• Sterility testing

• Clean air/water analysis

• Hygiene & bacteriology

• Quality monitoring

Global Strengths• One single database

• Identical lab reports worldwide

• Customized flagging

• Global quality assurance

• One key contact eases communication

Customized Analytical Services• Biomarker development

• PBMC cell separation

• Assay development

• Method validation

• Pharmacogenomics

• Rapid processing of larger batches

Study-specific Services• Visit-specific kit building

• Extended sample storage

• Worldwide shipping logistics

• Customized data management

• Secure online access to data

Bio-Analytical Services• PK/PD drug assays

• Structure elucidation

• Identification of metabolites

• Small/large molecules

• Bioassays

• Cell based assays

• Immunogenicity

South America

South Africa

Near and Middle East

Asia/China

Australia

India

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Global Quality Management

SYNLAB Pharma offers a unique range of laboratory services always working in accordance with the highest available standards such as: GLP, GCLP, GCP, GMP, DIN EN ISO /IEC 17025/15189.

Quality implementationIn addition to our own comprehensive quality procedures, SYNLAB Pharma undergoes periodic audits from customers as well as inspections from national and international regulatory authorities including FDA, Swissmedic and German competent authorities. In addition all our clinical laboratories are accredited by national accredition services (DAkkS, SAS). This ensures an ongoing review of all methods, procedures and results with continuous improvement of all established processes.

International quality systemSYNLAB Pharma guarantees that all services rendered are provided by continuously trained professionals who know the importance of each individual sample received. Periodic audits of all laboratory facilities are performed by our QA team. Rigorous cross-validation ensures comparability of global lab results.

Highest IT standardsOur IT platforms enable the dispatch of lab reports all over the world to display identical layout, content and flagging criteria. Secure online access is standard.

SYNLAB Pharma pairs the technology and the advantage of economies-of-scale of our reference laboratory with the flexibility and responsiveness of our clinical trials division to deliver the flexibility and high quality sponsors de-serve. Global reach is available via our laboratory network with facilities in Eu-rope, North and South America, South Africa, Near and Middle East, Australia, Asia and India. Periodic audits and cross-validations ensure data comparability through test correlations and evaluation of data accuracy and precision. Our dedicated project teams supervise and coordinate all global activities. This re-sults in highly reliable shipping logistics and clean electronic data transfers.

Central Lab Services

North America

SA

S_I

MA

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I_IN

T_E

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8201

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SYNLAB Analytics & Services Germany GmbH Gubener Str. 39 86156 Augsburg

pharma@synlab.comwww.synlab.de