Quality standards

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,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-6.6.0,vc_responsive

>> History | About us | Facilities

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)

2017

GMP
(Extension)

2018

FDA
Inspection

2019

Inspection
GMP facility