BioDuro sell "Process Development"
Basic Information
238
6
5
4.6(15)
Category
Subcategory & Sub-subcategory
Trade Type
Sell
Service Name
Process Development
Service Provider(s)
Specifications
- Application: Supports drug substance and intermediate manufacturing across route design and evaluation, process optimization, and scale-up from GLP toxicology through IND-enabling, clinical and commercial production
- Certification Standard: Process development conducted to GLP standards supporting toxicology and IND-enabling study requirements
- Regulatory Status: Services support regulatory submissions spanning GLP toxicology studies, IND-enabling studies and clinical/commercial manufacturing filings
Documents
GMP
ISO
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