LAZ GmbH & Co. KG

Sector(s):
Institution / Head office: 
Laboratory for Testing Medicinal Products and Registration Advice
Summary: 

LAZ offers a broad spectrum of laboratory services: analytical method development and validation (according to ICH, EU and FDA requirements), various kinds of quality related testing of APIs, excipients, drug products, primary packagings and medical devices. LAZ also provides full microbiological services for drug products.

Description: 

The spectrum of laboratory services and consultation encloses the development and validation of test methods, quality controls (APIs, excipients, drug products, primary packagings and medical devices), compatibility and stability studies of pharmaceuticals, residue analysis, and microbiology. All services are carried out considering the topical national and international regulatory demands and under GMP conditions. The laboratories are approved by competent authorities for GMP compliance and were successfully inspected by the FDA in 2009.

Analytical Services

LAZ offers analytical method development and validation (according to ICH, EU and FDA requirements), and various kinds of quality related testing of APIs, drug products and primary packagings.

  • Identity • assay • purity (starting material – intermediate – API – finished product)
  • Stability testing including forced degradation
  • Dissolution
  • Container/closure testing
  • Leachables/extractables
  • Residue analysis (solvents, ethylene oxide, catalysts, heavy metals, mycotoxines)
  • Analysis by AAS

Microbiological Services

LAZ offers full microbiological services for drug products, APIs and excipients including validation studies.

  • Microbiological quality of drug products, APIs and excipients according to Ph. Eur.
  • Development and validation of microbiological methods
  • Testing for efficacy of antimicrobiological preservation according to Ph. Eur. (Challenge Test)
  • Antimicrobiological effectiveness testing according to USP / NF
  • Microbial Monitoring
  • Bacterial endotoxins
  • Bioburden
  • Microbiological assay of antibiotics
  • Microbiological control of environments

Across our group of affiliated companies we offer all services in combination with dedicated project management; where appropriate in cooperation with partners form our network:

HWI Analytik GmbH (partner for reference standards; drug safety & non-clinical assessment; pharmaceutical analysis) www.hwi-analytik.com

i-Dras GmbH (partner for international drug regulatory affairs services)
www.i-dras.com

Sercona GmbH (partner for pharmaceutical research and product development)
www.sercona.org

Address: 

LAZ GmbH & Co. KG

Laboratory for Testing Medicinal Products and Registration Advice

Dischingerweg 15 | D-72070 Tübingen | Germany

Phone +49 (70 71) 96 52 07-0 • Fax +49 (70 71) 96 52 07 27

www.laz-labor.com

Email contact form
Website: 
http://www.laz-labor.de/en/index2.html