GBA Pharma Labs
Analytical services support domestic and international customers
Our locations for analytical services support 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.
GBA Pharma Labs run three GMP-certified and FDA-inspected sites in Germany with more than 160 highly qualified employees and over 4,500 m2 of lab space. 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.
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