ARL Bio Pharma sell "Pre-Clinical and Clinical Analytical Testing"
Basic Information
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Category
Subcategory & Sub-subcategory
Trade Type
Sell
Service Name
Pre-Clinical and Clinical Analytical Testing
Service Provider(s)
Specifications
- Application: CMC (chemistry, manufacturing and controls) analytical testing services supporting original and abbreviated new drug applications, including identification testing, quantitative and limit impurity testing, dissolution/disintegration performance testing, a
- Certification Standard: Testing programs designed to support both original (NDA) and abbreviated (ANDA) new drug application submissions
- Purity: Includes quantitative and limit-based impurity testing and control as part of the CMC testing scope
Documents
FDA
GMP
ISO
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