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Analytical Services

Our locations for analytical services support you in the development, approval process, and quality control of your products with an extensive range of services.

The analytical services division of the GBA Pharma consists of two sites in Munich (former LPU Labor für Pharma- und Umweltanalytik GmbH located in Gräfelfing and Martinsried) and in (Neu)-Ulm (former Phytos Labor für Arzneimittelanalytik GmbH & Co. KG). 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 base by providing reliable and faithful cooperation.

Operating under cGMP with more than 150 employees and over 5,000 m² of laboratory space, the 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, and US(FDA)-GMP, 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 or pharmacopoeia testing, e.g. Ph.Eur., USP, JP, BP)
  • 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
  • Release of 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. genotoxic impurities)
  • Analysis of elemental impurities, USP <232>, <233>, ICH Q3D and metal testing
  • Extractables & Leachables Studies
  • Microbiological Examinations
  • 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

GBA PHARMA GMBH

Messetermine

24. - 26. Oktober 2017
CPhI Frankfurt
Halle 4, Stand C35

Aktuelles

Pharmacelsus GmbH, Saarbrücken, ist neues Mitglied der GBA Laborgruppe

Im  Februar ist es uns gelungen, die Pharmacelsus GmbH mit Sitz in Saar­brücken, Deutschland, als Erweiterung unseres Dienstleistungs­portfolios im Pharmabereich zu ge­winnen. Pharma­celsus ist eine inter­nationale agieren­de Contract Research Organisa­tion, die seit mehr als 15 Jahren prä­klinische Dienst­leistungen in den Be­reichen in vitro ADME/T, in vivo Phar­makokinetik und Pharmakologie sowie Bioanalytik (GLP und Non-GLP) anbietet. weiterlesen