Quality standards - Labor Dr. Merk in Ochsenhausen, Germany
GLP certified testing facilitiy GMP certification, Medicinal Products Act, Animal Vaccines Act, Epizootic Deseases Act, BSL 2 (Biosafety level 2) organism, IfSG, S2 permission, GenTG, realization of ambitious ideas, analytical ventures, PEI approval for IVD, ISO 9001, ISO 13485, FDA Inspection, FDA Inspection Germany
482
page-template,page-template-full_width,page-template-full_width-php,page,page-id-482,page-child,parent-pageid-415,cookies-not-set,ajax_fade,page_not_loaded,,qode-title-hidden,qode_grid_1300,footer_responsive_adv,qode-child-theme-ver-1.0.0,qode-theme-ver-13.6,qode-theme-bridge,disabled_footer_top,wpb-js-composer js-comp-ver-6.2.0,vc_responsive
Guaranteeing excellent quality concerning all activities carried out at Labor Dr. Merk & Kollegen is our top priority. We ensure that all our services, ranging from expert consultations and the professional supervision of your projects to the realization of ambitious ideas concerning both analytical ventures as well as the manufacturing of viral therapeutics, adhere to the highest quality standards. For this, we follow leading national and international guidelines and continually adapt our practices to novel requirements.
Quality Standards
GLP certified testing facility
GMP certification
External testing laboratory according to §14 and §64 AMG (Medicinal Products Act)
Testing laboratory for animal vaccines according to §13 TierImpfStV (Animal
Vaccines Act) and §17a TierSG (Epizootic Diseases Act)
Permissions
Permission to work with BSL 2 (Biosafety level 2) organisms according to
IfSG and TierSeuchErV
S2 permission according to GenTG
LMK Quality Certification / Inspections
1975
PEI approval
for IVD
2003
ISO 9001,
ISO 13485
(Medical Devices)
2008
GMP
(Produt Release)
2013
GLP
(Clearance Studies)
2019
Inspection
GMP facility
1975
PEI approval
for IVD
2003
ISO 9001,
ISO 13485
(Medical Devices)
2008
GMP
(Produt Release)
2013
GLP
(Clearance Studies)