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BIOCHEM KARLSRUHE GERMANY COMPANY PRESENTATION Welcome to the world of BioChem COMPANY PRESENTATION DECEMBER 2017 BIOCHEM KARLSRUHE GERMANY COMPANY PRESENTATION BioChem analytical laboratory one of the leading German- based analytical
COMPANY PRESENTATION DECEMBER 2017
BIOCHEM KARLSRUHE GERMANY
COMPANY PRESENTATION
COMPANY PRESENTATION DECEMBER 2017
BIOCHEM KARLSRUHE GERMANY
▪
based analytical laboratories ▪ more than 40 years of experience ▪ independent, family-owned ▪ located in Karlsruhe, south-west Germany ▪ expertise of more than 80 in-house specialists ▪ three core competencies:
COMPANY PRESENTATION DECEMBER 2017
BIOCHEM KARLSRUHE GERMANY
quality approved full service provider: ▪ GMP-certified (last inspection: April 2017) ▪ GLP-certified (last inspection: December 2017) ▪ FDA-registered and successfully inspected
(last inspection November 2017)
▪
▪ regular self-inspections
COMPANY PRESENTATION DECEMBER 2017
BIOCHEM KARLSRUHE GERMANY
authorisation for …
▪ handling of narcotics according to §3 BtmG ▪ handling of narcotic precursor according to GÜG and (EG) 273/2004 Art. 3 Abs. 2 of category 1 substances ▪
and GenTAufzV as well as GenTSV of security level 1 and 2 according to GenTSV (biosafety level 2 GMOs on a project-by- project basis only) Furthermore BioChem has notified competent authorities about: ▪ handling of pathogenic organisms according to §§ 44 IfsG ▪ handling of epizootic disease germs according to TierSeuchErV
COMPANY PRESENTATION DECEMBER 2017
BIOCHEM KARLSRUHE GERMANY
▪ internationally active: customers e.g. from Europe, Russia, China, Japan, Singapore, Jordan, Saudi-Arabia, Israel, USA, Mexico, Brazil ▪ Customers: life science industry
COMPANY PRESENTATION DECEMBER 2017
BIOCHEM KARLSRUHE GERMANY
▪ quality control and development testing ▪ all dosage forms ▪ method development, transfer and validation ▪ identity, assay, purity and residue ▪ cleaning validation ▪ release and stability testing ▪ EU re-analysis ▪ storage according to ICH-guidelines ▪ GMP-/GLP-like documentation ▪ testing procedures, protocols and reports ▪ registration and submission support
COMPANY PRESENTATION DECEMBER 2017
BIOCHEM KARLSRUHE GERMANY
COMPANY PRESENTATION DECEMBER 2017
BIOCHEM KARLSRUHE GERMANY
excerpt from our microbiological portfolio: ▪ bacterial endotoxin testing ▪ assay of antibiotics ▪ sterility testing ▪ efficacy of preservation testing ▪ microbial contamination testing ▪ environmental monitoring ▪ non-routine testing and special testing for almost all microbiological questions
For more details please contact our experts.
COMPANY PRESENTATION DECEMBER 2017
BIOCHEM KARLSRUHE GERMANY
For more details please contact our experts.
excerpt from our analytical portfolio: ▪ chromatography ▪ spectroscopy ▪ elemental analysis ▪ physico-chemical testing ▪ dissolution testing ▪ stability testing
COMPANY PRESENTATION DECEMBER 2017
BIOCHEM KARLSRUHE GERMANY
excerpt from our molecular biological/bioanalytical portfolio: ▪ DNA/RNA testing ▪ protein/antibody testing ▪ biotechnological product testing ▪ bioassay/enzymatic assay ▪ biological contamination testing
For more details please contact our experts.
COMPANY PRESENTATION DECEMBER 2017
BIOCHEM KARLSRUHE GERMANY
BioChem Labor für biologische und chemische Analytik GmbH
Daimlerstraße 5b | 76185 Karlsruhe, Germany | Phone: +49 721 9737-0 E-Mail: biochem@biochem.de | www.biochem.de A member of the BioChem Group