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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

News

GBA Laboratory Group to Hold Lecture at the Concept Heidelberg Seminar: “Regulatory Compliance Expert”

CONCEPT HEIDELBERG will hold an advanced training seminar on the topic “Pharmaceutical authorization for people working in a GMP setting” in Karlsruhe on October 20th and 21st, 2016. With Dr. Johannes Rzepka, Head of the Regulatory Affairs Department at our location in Gräfelfing – LPU Labor für Pharma- und Umweltanalytik GmbH – the GBA Laboratory Group provides a highly competent lecturer who will present on the topic: “Information from the GMP environment for the application dossier: analysis and quality control.” more

GBA Laboratory Group Now Represented in Governing Body of the VUP

The GBA Laboratory Group is now represented within the governing body of the German Association for Independent Test Laboratories (VUP – Deutscher Verband Unabhängiger Prüflaboratorien e.V.). At the general assembly on September 8th, 2016, Dr. Andreas Hofmann from our location in Neu-Ulm – Phytos Labor für Analytik von Arzneimitteln GmbH & Co. KG – was elected to the five-person team. The focus for the next two years will be placed on strengthening the attractiveness and the clout of the laboratory association, which has grown strongly in recent years. Especially in terms of politics, governme more

GBA Laboratory Group to Hold Presentation at CPhI 2016 in Barcelona: EU-Import from Non-EU-Countries, Our Concept and Our Solutions to this Challenge

In a second presentation, also as part of the Insight Briefings at the CPhI 2016 in Barcelona, the GBA Laboratory Group’s Pharmaceutical Division will explain some of the special aspects of the European pharmaceutical market. Marco Zeller, a representative from our location in Neu-Ulm (Phytos Labor für Analytik von Arzneimitteln GmbH & Co. KG) will present potential solutions for how business from non-EU countries can tap into the European pharmaceutical market. The European Union, which currently has 28 member states, is still a growing market for the sales of pharmaceuticals. Europe account more