explicat® Pharma GmbH - your service provider for Technical Project Management - strengthened its forces in relation to Quality Assurance/Auditing Services.
Our Team Members Dr. Jana Marsalkova and Dr. Jaroslav Marsalek both now perform Auditing for ISO 9001, GMP for cosmetics, ISO 13485 (medical device and in vitro diagnostics industry) and GMP for medicinal products (EC-GMP's). Moreover, Dr. Jana Marsalkova is an official Lead Auditor with IRCA (International Register of Certified Auditors, www.irca.org, see Auditor grades). Both may perform the audits not only in english, but also in cz or slovak or russian language.
We are pleased to provide more information about our expanded services, and welcome working with you regarding your Audit needs.
New Testing Equipment:
Delsa™ Nano C Laserlight Scattering
LS™ 13 320 Series Laser Diffraction Particle Size Analyzer
October 6th 2011: CBA, our analytical partner, has been recertified by the competent authority of Saarland. The renewed GMP Manufacturing License includes facilities for analytical testing and release of raw materials, intermediate drug products and investigational medicinal products to.
CBA has received the allowance to release also investigational medicinal products for clinical studies. CBA's QP is Dr. Andrea Weiland, one of explicat®'s managing directors. It is explicat®'s and CBA's joint strategy not to only to provide excellent formulation and analytical development service but also to enable our partners to use our manufacturing license for the release of both medicinal products to the market as well as investigated medicinal products for clinical studies.