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