Pharmazeutische und chemische Entwicklungsgesellschaft mbH Formula-Pharma
 
     
     
   
 
 
 
 
 
 
 
 
Pharmaceutical and Analytical Development
  • Development of analytical methods for drug substances and products
  • Pharmaceutical investigations in accordance with international pharmakopoes
    (e.g. Pharm.Eur., USP, BP)
  • Validation of analytical methods corresponding to Note For Guidance On Validation
    Of Analytical Methods/Procedures
  • Stability testing of drug substances and products corresponding to Note For Guidance
    On Stabilty Testing
  • In-use stability testing of human medicinal products (CPMP)
  • Stability testing of biotechnological/biological products corresponding to Note For
    Guidance On Quality Of Biotechnological Products
  • Storage of drug substances and products in climatic zones I to IV and under accelerated
    conditions (CPMP/ICH)
  • Photostability testing of drug substances and products (CPMP/ICH)
  • Identification and isolation of degradation products and impurities in drug substances
    and products.
  • Biopharmaceutical testing of drug products according to Guidance for Industry
  • Analytical testing and confirmation in accordance with 14 AMG (signed by head of
    quality control, AMG)
  • Analytical release of starting materials for GMP-manufacturing (API, excipients,
    intermediate products if appropriate)
  • On-going stability testing under GMP-conditions
  • Accompanying analytical testing for validation of manufacturing processes
  • Container Integrity-test