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•Product Brochure: Sterile Development Technologies Stability Studies Capabilities

Leading the contract industry with laboratory and chamber capacity, operational excellence, on-time delivery of reports, and effective regulatory assessment— Catalent provides unique partnering efficiencies to ensure advancement of a product candidate through development and registration as well as providing complete commercial product support.

Catalent assesses stability of a drug by employing appropriate physical, chemical, biological and microbiological testing. The results of this testing are linked to:

• Stability indicating method development and validation
• Comprehensive knowledge of global and regional regulatory requirements
• Protocol design appropriate to stage of product life cycle
• Determination of shelf life with statistical analysis and data trending

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•Product Brochure: Sterile Development Technologies Stability Studies Capabilities

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