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