Articles

In this rapidly changing environment, your choice of CDMO partner is critical. The right partnership can serve as your key to commercial success, while the wrong one can lead to costly delays, quality issues and compliance risks. To help you overcome your OSD challenges and drug product manufacturing challenges and streamline your journey to commercialization, our experts have developed an eBook to help you find the right CDMO for your project.

Discovery to Commercialization: The Right Partnerships are Key to Streamlined Drug Development

This whitepaper explores the importance of safe cGMP pharma product storage, highlighting challenges CDMOs face with inventory bottlenecks and delays. It examines off-site cGMP storage benefits, including cost savings, flexibility, and compliance, while addressing key factors for maintaining product safety and accessibility.

Selecting an Off-Site cGMP Storage Provider

Elemental impurity testing is essential to deliver safe drug products to patients and is a regulatory requirement. It is important to assess the risk of elemental impurities from all sources in the manufacturing process, including process equipment, water, container/packaging, raw materials, drug substances, and the final drug product.

ICP-MS and ICP-OES: Tools for Elemental Impurity Analysis

Compendial testing covers a wide array of materials, subjects, and locations designed to create standards and programs that ensure the quality and safety of approved articles for a geographical location or areas such as USP (For the United States market) or Ph Eur (For European markets). The compendia provide monographs and test methods for active ingredients, raw materials, drug products, utilities (water and gases), and packaging components.

Outsourcing Compendial Testing for Competitive Advantage

Designing a Strategic Roadmap for Seamless Product Development 

Revolutionize pharmaceutical manufacturing through paperless manufacturing. By eliminating paper-based processes, you can quickly centralize your data, reduce cost and time, minimize errors, and release products faster. Even the simplest “paper on glass” digital systems enable streamlined workflows and can ensure real-time data access and seamless communication. Paperless facilities are a reality! Transform your operations today!

Make Paperless Manufacturing a Reality for your Pharmaceutical Facility

Amid surging drug shortages and costly launch delays, it’s crucial to enhance operational flexibility and efficiency without compromising quality. Discover how end-to- end integrated automation systems can streamline your processes, improve flexibility, reduce time-to-market, maximize revenue, and drive continuous improvement. Transform your pharmaceutical manufacturing processes today! 

All Whitepapers