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Pharma

SYNLAB Pharma offers companies in the pharmaceutical, biotechnology and cosmetics sectors, as well as manufacturers of medical devices and novel foods, a wide range of analytical methods for both clinical and preclinical studies, as well as for quality control.

We support our customers in all areas, offering them a comprehensive service that covers all needs, from collection of the sample to delivery of the result.

All services are controlled according to the highest quality standards. The laboratory where the analyses are performed works with: GLP, GCLP, GCP, GMP, DIN/EN ISO/IEC 17025/15189

In addition to our comprehensive quality procedures, SYNLAB Pharma regularly undergoes customer audits as well as inspections by national and international regulatory authorities.

All our clinical laboratories are accredited by national accreditation services (DAkkS, SAS, ENAC). This ensures a continuous review of all methods, procedures and results with a continuous improvement of all established processes.

Scientific experience

We are backed by extensive scientific experience in our offer of:

Biological services

Customized analytical services

Clinical trial services

GMP analytical services for pharmaceutical products and substances

Production support

Quality system

360º Service 
automation and traceability

  • 01
    Project management

    A Project Manager assigned to their project

    Single contact person

    Onmedicall platform

  • 02
    Global logistics for samples

    Extensive national and international transport network

    Coverage > 40 countries

    Shipments between 24-48 hours

    Ambient temperature / between 2-6ºC / dry ice

  • 03
    Kits

    Preparation of customized kits for each assay

    Stock control

    Shipping to the centres

  • 04
    Quality assurance

    GLP, GCP, GMP

    DIN/EN ISO/IEC 17025/15189

    ISO 9001/14001

  • 05
    Data

    Integrated reporting

    A single database

    Customized data management

    System of alerts according to their needs

    Data protection/confidentiality

    Online Portal, secure access to results

    Sample storage

    Statistics and bioinformatics

What do we offer?

1. PHARMACEUTICAL PRODUCTS

We offer a wide range of analytical services, supporting our customers from the discovery of a drug, through the pre-clinical and clinical phase, to the studies for the manufacture of the final pharmaceutical product.

2. BIOLOGICALS

We develop and implement biological strategies for the analysis of therapeutic proteins, advanced therapy medicinal products (ATMP) and biosimilars. The drug production process is supported by our extensive experience in conducting bioassays and physico-chemical analyses under GMP. Other areas of expertise are: PK and PD, biomarkers and immunogenicity testing, including the development, optimization and validation of assays.

3. COSMETICS

We support all stages of cosmetics production. We offer analytical consulting and quality control, physico-chemical methods, stability studies under defined environmental conditions, and microbiological and in-use stability testing. Quality controls are performed in accordance with EP, USP or other requirements of the customer.

4. RELEASE AND STABILITY

We conduct stability studies according to ICH Q1A (R2), including consulting, planning, storage and analysis. In addition, we offer SYNLAB our support in all stages for a successful drug approval: long-term, intermediate and accelerated stability studies; ongoing and follow-up stability studies, stress tests (including stability phototests) and compatibility studies.

5. REGULATORY ASPECTS

We design regulatory projects for early- and late-stage development, including consultation with regulatory agencies (scientific advice and clinical trial applications).

6. MEDICAL DEVICES

We have experience in performing biocompatibility testing (ISO 10993), leaching and extraction studies, toxicological and microbiological testing of medical devices for biological evaluation in development, registration and production.

7. DIETARY FOODS FOR SPECIAL MEDICAL PURPOSES (FSMPS)

SYNLAB Pharma is the expert laboratory in GLP, GMP and GCP during the R&D and manufacturing phase of novel foods according to European guidelines (1223/2009). The analytical services include bioanalytical testing, hygiene, microbiology and toxicology testing, and clinical trial services.

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