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Accreditations and Certifications

SYNLAB pharma has a full set of accreditations and certifications including the following:

  • GMP
  • GLP
  • DIN EN ISO 9001
  • DIN EN ISO 17025
  • DIN EN ISO 15189 (CAP equivalent)

Our quality management system fulfils all the requirements of GCLP and GCP. The laboratories are regularly inspected by regulatory authorities including

  • FDA
  • OECD
  • UKAS
  • DAkkS
  • DQS
  • plus various others for those laboratories outside Europe

SYNLAB pharma participates in External Quality Assurance schemes with the following bodies:

  • INSTAND, Germany
  • RIQAS, United Kingdom
  • UK NEQAS, United Kingdom
  • WEQAS, United Kingdom
  • further certifications and accreditations are available on request for partner laboratories outside Europe.
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Fellbach wird neuer Laborstandort
Nach zweijähriger Planungs- und Umbauphase entstand in Fellbach das neue Labor der SYNLAB Analytics & Services Germany GmbH.
Aug 10, 2018 Continue
Determination of the Impurity N-Nitroso dimethyl amine (NDMA) in Drug Substances with GC-MS

Due to contamination of a drug substance with the potential mutagenic substance N-Nitroso dimethyl amine (NDMA) a massive recall campaign was initiated for the related drug products. SYNLAB Pharma offers a GC-MS test for testing the absence of NDMA in drug substances and drug products.

Please contact our experts.

Jul 13, 2018 | Pharma Continue
New Services in Regulatory Compliance for Biologics

With immediate effect, SYNLAB Pharma provides a broad support in the field of Regulatory Compliance of Biologics development. With this new services we support specifically start-ups, small to medium sized biotech companies, which require professional consultancy and project execution in regulatory project design.

For further questions, please contact:

Jun 18, 2018 | Pharma Continue
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