Simplify the Journey^TM with Integrated Solutions

Whether you are developing a biologic, pharmaceutical or generic product, West knows the challenges you face along the drug development journey because we live it with you. And for more than 95 years, we’ve been developing and refining our expertise in packaging, device and combination product solutions to help our partners deliver important treatments to patients.

West offers integrated solution packages for Prescreen and Compatibility, Clinical Phase I, II, and III, Lifecycle Management and Generics across all injectable formats. Tailored to the unique needs of your biologic, pharmaceutical or generic drug product, West’s product/service solutions can Simplify the Journey™ from molecule to patient by:

• Reducing development and supply risk
• Accelerating your path to market
• Minimizing total cost of ownership
• Improving the patient experience

With Integrated Solutions, you get a comprehensive program that provides a primary package backed by the scientific knowledge you need to mitigate risk and make a fast move to market. Our experts specialize in:

• Extractables and Leachables Analysis
• Packaging and Device / Combination Product Testing
• Particle Analysis
• Container Closure Integrity  Analysis and Techniques

Learn more here.

Provide industry-leading support to West's customers, who operate within the highly regulated spaces of pharmaceuticals, biologics and medical device development. We offer Integrated Solutions around:

• Regulatory Guidance
• LOA
• DMF Support
• Certifications
• IFU Support
• Human factor study design and evaluation
• Delivery system
• Device Filings

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Becoming involved during early phases of product development enables West to optimize the design, which can yield significant short-term and long-term benefits, including improved cycle times, lower scrap, lower capital costs and lower long-term maintenance costs. Our design services include:

• System performance evaluation
• Container/system testing
• User Preference studies for device
• Design verification
• Packaging/device customization
• Design history file creation

West offers a variety of device contract manufacturing services, including:

• Device Assembly
• Drug Handling
• Product Track & Trace / Serialization
• Final Packaging

• Product Filling/ System Fit Services
• Equipment vendor and CMO selection consulting
• Process development engineering services
• Filling line URS development services
• Component change and machinability assessments
• Troubleshooting and investigation
• Technology and process transfer

Integrated Solutions Proposal Overview

Integrated Solutions Overview - Generics

Drug Handling Information Sheet