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Pharmaceutical Services

  • Cooperation and support with the evaluation and selection of suppliers of active pharmaceutical ingredients (APIs)
  • Regulatory support in the addition of alternative additional API suppliers into existing marketing authorisations and registration dossiers
  • Cooperation in the evaluation of contract manufacturers
  • Evaluation and support of site transfers of the manufacture of medicinal products with project management tools
  • Regulatory and pharmaceutical support of site transfers for the manufacture of medicinal products
  • Support with evaluation and selection of analytical laboratories for the chemical-pharmaceutical analysis of medicinal products, also covering long term (stability) studies
  • Support regarding agreements and contracts on the tasks and division of responsibilities in contract manufacturing with your partners
  • Maintenance of your existing Quality Management System and, upon request, update and/or revision of it
  • Compilation / revision of Quality Management Handbook exactly tailored to your company situation and compilation of relevant related Standard Operating Procedures (SOPs)
  • Support with translations of product information texts and other medicinal texts, review of provided translations and implementation of necessary corrections