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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-GMP, 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

Members of the GBA Laboratory Group

Exhibition Dates

24. - 26. October 2017
CPhI Frankfurt
Hall 4, Stand C35

News

Pharmaceutical Quality Control: Tips, Tools & Tactics - Seminar with Dr. Xaver Schratt

On April 6th and 7th, a seminar will be held by LGC in Potsdam about the topic of “Pharmaceutical Quality Control: Tips, Tools & Tactics.” Dr. Xaver Schratt, member of GBA Laboratory Group’s site of LPU in Martinsried, Germany, will be reporting on practical aspects of validating analytical methods in the pharmaceutical field. The main focus will be placed on commonly occurring errors and how they can be avoided. Furthermore, common misunderstandings will be discussed and explained using practical examples. more

Pharmacelsus GmbH, in Saarbrücken, Has Become a Member of the GBA Laboratory Group

In February, we were successful in ac­quiring Pharmacelsus GmbH, located in Saarbrücken, Germany, as new member of the GBA Laboratory Group, further expanding our range of services in the pharmaceutical field. Pharmacelsus is an internationally operating contract research organi­zation that has been offering precli­nical services in the fields of in-vitro ADME/T, in vivo pharmacoki­netics and pharmacology, as well as bioanalysis (GLP and non-GLP) for over 15 years. more