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.
We are backed by extensive scientific experience in our offer of:
Customized analytical services
Clinical trial services
GMP analytical services for pharmaceutical products and substances
automation and traceability
A Project Manager assigned to their project
Single contact person
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
Preparation of customized kits for each assay
Shipping to the centres
GLP, GCP, GMP
DIN/EN ISO/IEC 17025/15189
A single database
Customized data management
System of alerts according to their needs
Online Portal, secure access to results
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.
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.
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.