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LAB EXPERTS ATYOUR SIDEOver twentyfive years of experience

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About usFor our clients in the pharmaceutical, biotechnology and cosmetics indus-tries as well as for manufacturers of medical devices and novel foods SYNLAB Pharma offers a broad portfolio of analytical methods for clinical and preclinical studies 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 DIN/EN ISO/ IEC 17025/15189, GMP, GLP, GCLP or GCP.

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. By networking our specialized laboratories, we can offer you all services from a single source, even for complex requirements.

As part of the SYNLAB Group, we are part 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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Foods for Special Medical

Purposes (FSMPs)SYNLAB Pharma is the GLP, GMP

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

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

trial services.

What we offer

BiopharmaceuticalsSYNLAB Pharma develops and

implements strategies for the analysis of innovative products, bio similars and

biobetters. Only to name some areas of expertise: PK and PD, biomarkers and immuno-genicity including assay development, optimi-zation and validation. In addition, the drug

production process is supported by our broad experience in running

bioassays for release and stability testing.

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 product registration: Long­term, intermediate and accelerated

stability; ongoing and follow­up stability studies, stress testing (including

photo­stability testing), and compatibility studies.

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.

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 demanding projects across the entire life

cycle of a pharmaceutical product.

Discovery Pre-clinical / Early development

Clinical Research & Development Approval CommercialPhase 1 Phase 2 Phase 3 Launch Phase 4

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DRUG PRODUCTS

MEDICAL DEVICES

HUMAN DIAGNOSTICS

Covering the whole lifecycle of your product

Genomics: Sequencing, Genotyping, Pharmacogenomics

Early Clinical Development: Clinical Pharmacology, Biometrics

Speciality Diagnostics: Infecious Disease & Molecular, Companion Diagnostics, Immune Response, Allergy/Hypersensitivity, Anatomic Pathology

Central Laboratory: Safety, Biomarkers, Bioanalysis, Infectious Disease Services, Global Clinical Trials

Bioanalytical: Bioavailability, PK/TK, Immunogenicity, NAb, Biomarkers, Bioequivalence

Pre-clinical / Early development Pharmacology, Safety, Toxicity, Bioanalysis (PK/TK)

Development & Approval: Regulatory Support, Physico – chemical analysis, microbiology, sterility, cytotoxicity, biocompatibility testing

Biologics & Small Molecules Product Testing: GLP, GMP, Stability, Quality Control, Microbiological Testing, Process Development, Potency Assays, Impurity Tracking

Pharmaceutical Development Characterization, Chemistry, Toxicity, Reference Standards

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

Pharmacopeia (EP/USP)

• GMP storage

• Stability testing 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

• Handling of controlled substances

Analytical Expertise

GCP, GCLP, GLP & GMP for• Pharma

• Biotech

• Medical Devices

• Novel Foods

• Cosmetics

• Crop Protection Agents

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 DIN/EN ISO / IEC 17025/15189, GMP, GLP, GCLP or GCP.

Quality implementationIn addition to our own comprehensive quality procedures, SYNLAB Pharma undergoes periodic audits from customers as well as from national and international regulatory authorities including DAkkS, FDA and Swissmedic. 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 deserve. Global reach is available via our laboratory network with facilities in Europe, 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 results in highly reliable shipping logistics and clean electronic data transfers.

Central Lab Services

North America

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

pharma@synlab.comwww.synlab.de