Pharmatory Oy / Ltd. offer service "Contract manufacturing and analytical services"
Basic Information
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35
17
3.6(55)
Category
Subcategory & Sub-subcategory
Trade Type
Offer Service
Service Name
Contract manufacturing and analytical services
Service Provider(s)
Specifications
- Study Conditions: Runs ICH stability studies alongside cGMP manufacturing of APIs and key intermediates, supporting a full CMC data package.
- Protocol Design: Degradation studies are designed alongside process and analytical method validation to characterize impurity formation over time.
- ICH Zone Coverage: Drug master file compilation and maintenance, together with comprehensive documentation, support stability data submission across relevant ICH climatic zones.
Documents
GMP
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