Pharmazeutische und chemische Entwicklungsgesellschaft mbH Formula-Pharma
 
     
     
   
 
 
 
 
 
 
 
 
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:
  • Formulation of pharmaceutical products: solid, liquid and
    injectable forms
  • Lyophilization technology
  • GMP-Quality control of starting material, packaging material,
    intermediate, bulk and finished products
  • Manufacturing licence in accordance with §13 AMG
  • Manufacturing of clinical supplies in accordance with §13 AMWHV
  • Analytical release of clinical supplies and medicinal products in
    accordance with §14 AMWHV
  • Release for market or clinical study in accordance with §16 AMWHV
  • Import and EU-release of clinical supplies, comparator products and
    medicinal products manufactured in non-EU countries (§72 AMG)
  • External Inspection by Qualified Person of pharmaceutical
    manufacturers (API and medicinal products)
  • Screening of packaging materials
  • Up scaling and validation of processes
  • Development and validation of analytical methods (CPMP)
  • Storage of API, clinical supplies and medicinal products in climatic
    chambers: 25°C, 60% RH, 30°C, 65% RH, 40°C, 75% RH, 5°C and
    storage at custom specified conditions
  • Stability testing and in-use stability (CPMP/ICH)
  • On-going stability (GMP-conditions)
  • Quality documentation (CTD Module 3)
  • Support in regulatory affairs
  • Development of nutrition supplement products
  • Synthesis of drug substances
  • Purification, isolation and identification of degradation products in
    medicinal products and drug substances
  • Synthesis of special radioactive compounds