Contact

Facts and Figures

Field of expertise:Pharmaceutical, analytical and galenical development
Founded in:1995 (Amtsgericht Charlottenburg, HRB 55 301)
Managing Directors and Owners:Rudy Thoma and Dr. Christian Brätter
Employees:8
Turn over:~1 Mio €

Core activities

  • Lyophilization technology
  • Analytical development and validation of analytical methods (CPMP)
    • Development and validation of HPLC methods
    • Development and validation of GC methods
    • Development and validation of titrimetric methods
  • Stability testing and in-use stability (CPMP/ICH and on-going under GMP)
    • Climatic storage of API, clinical supplies and medicinal products in climatic chambers:
      • 25°C, 60 % RH (climatic zone II / long term)
      • 30°C, 65 % RH (climatic zone IVa / alternative long term and intermediate)
      • 30°C, 75 % RH (climatic zone IVb)
      • 40°C, 75 % RH (accelerated)
      • 2 -8°C (cooling conditions) and storage at custom specified conditions
    • Analytical testing after withdrawal from stability storage
  • Purification, isolation and identification of degradation products in medicinal products and drug substances
  • Screening of packaging materials / Blister packaging using different packaging materials
  • GMP-Quality control of starting material, packaging material, intermediate, bulk and finished products (QC-confirmation of medicinal products in accordance with 14 AMWHV)
  • Import (§72 AMG), re-test and release of medicinal products from non-EU countries (§§14, 16, 17 AMWHV)
  • GMP-service and audit by Qualified Person of pharmaceutical manufacturers (API/issuing of QP declaration and medicinal products)
  • Manufacturing of clinical supplies in accordance with §13 AMWHV
    • Procurement of comparator products, e.g. originator and the labeling as clinical supply
    • Analytical testing and on-going stability testing of clinical supplies in accordance with §14 AMWHV
    • Recording of dissolution-data based on CPMP/EWP/QWP/1401/98 Rev. 1/Corr **
    • Release for clinical studies in accordance with §16 AMWHV
    • Global shipment and distribution of clinical supplies to corresponding CRO, respectively
    • EU-Import of clinical supplies and formulations in bulk from non-EU countries (§72 AMG)
  • Applicant of market authorization inside the European Union as SME-granted company
    • Support and consulting regarding regulatory affairs inside the EU and quality check of the registration document (CTD)
    • Support and service regarding Pharmacovigilance, e.g. Site Master File for Pharmacovigilance (SMPV), Risk Management Plan (RMP), Qualified Person for Pharmacovigilance (QPPV), etc.