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Pharmaceutical Analysis

Pharmaceutical Analysis

Our location for pharmaceutical analysis supports you in the development, approval process, and quality control of your products with an extensive range of services

The pharmaceutical division of the GBA Laboratory Group consists of two com­panies: LPU Labor für Pharma- und Umweltanalytik GmbH (located in Gräfelfing and Martinsried) and Phytos Labor für Arzneimittelanalytik GmbH & Co. KG (based in Neu-Ulm). These subsidiaries can draw upon decades of experience in pharma­ceutical analysis and assisting with the pharmaceutical approval process in human and veterinary medicine. Over this time, they have been able to build up a global customer by providing reliable and faithful cooperation.

Operating under cGMP with more than 150 employees and over 5,000 m2 of laboratory space, the GBA Laboratory Group’s pharmaceutical division is your “one-stop shop” for analytical services. We provide our domestic and international customers, whether from the private industry or research institutions, with scientific and technical solutions for the development, approval process, and quality control throughout every step of the product lifecycle.

With a comprehensive range of services in the analytical and regulatory fields, we offer fast, flexible, and customer-oriented solutions. Our laboratories are certified according to EU-CMP, US(FDA)-GMP, and DIN EN ISO/IEC 17025:2005 and we have a manufacturing license based on §13 (1) AMG (German pharmaceutical law) as well as an import license based on §72 par. 1 AMG and the EU Regulation (EC) No 726/2004. Take advantage of our competent all-around service in the following fields, all from one source! 

  • Method development, validation, and transfer
  • Quality control (customer-specific testing instructions, Ph.Eur., USP, BP, JP, PPRC)
  • Stability studies (e.g. ICH, VICH) and sample storage management
  • Qualification, establishment, and management of reference standards (e.g. primary standards and working standards)
  • EU gate analysis
  • Releasing human and veterinary pharmaceuticals for marketing authorization (par. §13.1, QP service)
  • Release of clinical investigational products (QP service)
  • Residue and trace analyses (e.g. elemental impurities [ICH Q3D], genotoxic impurities)
  • Microbiological Examinations (incl. drinking water analysis)
  • Registration services (e.g. eCTD, all authorization processes)
  • R&D under GMP and non-GMP Standard
  • Consulting on all aspects of analysis, regulatory affairs, and pharmaceutical strategy

PHYTOS LPU

News

8th Food Safety Congress in Berlin

An essential event for the GBA Laboratory Group! This year, the 8th Food Safety Congress will take place in Berlin on June 7th and 8th, 2016. Within the ABION hotel’s event facilities and under the motto “Trust in Food – From the Producer to the Consumer,” numerous technical presentations will be held by renowned speakers from the business and from politics. The event will be rounded out with an interesting selection of workshops dealing with the topic of safety and pro­tection in the food industry. more

INGESA – The International Conference for Grain Production, in Velden, Austria

On June 2nd and 3rd, 2016, for the first time the GBA Laboratory Group will be represented with its own booth (B10) at the INGESA conference, which will be held at the Casino Velden in the town Velden am Wörthersee, Austria. more

Import License for Medicinal Products Granted

The import license for medicinal products acc. to § 72 a, section 1 AMG (German Medicinal Products Act ) and EU regulation 726/2004 was granted to our phar­maceutical laboratory Phytos Labor für Analytik von Arzneimitteln GmbH & Co. KG (Neu-Ulm) on March 17, 2016 by the state authorities of Bavaria, Germany (Regierung von Oberbayern, Munich). more