VelaLabs, your right choice for GMP compliant analytical characterization of biomolecules
Analytical Characterization of Biomolecules
VelaLabs was founded in 2006 in the former Novartis Campus in Vienna. Since 2007, it is a GMP-certified service-oriented company with focus on analytical and quality control of biopharmaceutical products, as well as clinical development of biosimilars, biologics and ATMPs. By the acquisition of LABH in 2019, VelaLabs can now also offer all types of microbiological services. Together with its strong team, the VelaLabs Management aims to successfully realize its vision of the future and expand its base of operations.
Among the new goals are digitalization and expansion of its analytical method portfolio for innovative products, as well as GLP certification and ISO 17025 accreditation.
Our philosophy is to support our customers during the journey through the adventure of health.
With our help you have a competent partner in your side for the whole process of drug development that supports you with analytical development, clinical expertise and regulatory consulting.
VelaLabs stands for individual customer support, highest quality standards and professional expertise and we are an international partner for the pharma and biotechnology industry developing biopharmaceuticals and biosimilars.
Our solutions are not out-of-the-box and our flexible and dynamic team can provide tailored solutions for our customers while also having regulatory expertise.
Certificates & Accreditations
VelaLabs offers analytical test methods for medicinal drugs in the preclinical and clinical development phase. The analytical portfolio is based on International Conference for Harmonization (ICH) guidelines and covers non-cellular and cellular methods. The portfolio is further completed by advisory support for submission-relevant clinical studies and drug product release.
The most important tool for assuring the quality standards of VelaLabs is the GMP certification, which represents the highest level of quality in the pharmaceutical industry. Furthermore, VelaLabs is working compliant with GCLP guidelines for all bioanalytical services.
|Jul 2020||Granted certificates for VelaLabs: GLP, GMP, ISO17020, ISO17025|
|Jan 2020||New Management Board: Markus Roucka, Albert Lauss, Klaus Hajszan|
|Jun 2019||Acquisition of the Laboratorium für Betriebshygiene GmbH (“LABH”)|
|Dec 2017||Revenues reach 4.7 million € (Export quote: 83%)|
|Dec 2017||In 2017, VelaLabs invested nearly 1,000,000 € to enhance its instrumental park|
|Feb 2017||Closing of Tentamus incorporation|
|Dec 2016||Revenues reach 4.0 million € (Export quote: 90%)|
|Dec 2016||DI (FH) Markus Roucka appointed as COO|
|Sep 2016||Celebration of 10 years VelaLabs|
|Jul 2016||AGES inspection and renewal of GMP certificate|
|May 2016||Acquisition of VelaLabs by Tentamus group|
|Aug 2015||Successful US FDA audit with focus on clinical development and bioanalytics|
|Jul 2014||EMA – first biosimilar batch release testing for the European market|
|Dec 2012||Vela sales reach 3 million € (Export quote: 88%)|
|May 2012||DI (FH) Klaus Hajszan appointed as Qualified Person|
|Oct 2011||Celebration: VelaLabs – 5 years on its way|
|Dec 2010||VelaLabs sales reach 1.9 million € (Export quote: 79%)|
|Dec 2009||VelaLabs sales reach 1.0 million € (Export quote: 65%)|
|Dec 2008||VelaLabs sales reach 0.5 million € (Export quote: 55%)|
|Nov 2007||GMP certificate for VelaLabs by AGES/PharmMed Austria|
|Apr 2007||Lease contract for analytical laboratories, first customer acquired for analytical service business|
|Oct 2006||Founding of VelaLabs, appointment of Dr. Markus Fido as Managing Director (CEO)|