Articles

Quality and Regulatory Sourcebook 2023

Critical considerations for deploying smart, fast, and flexible Life Sciences facilities

The Facility of the Future

Tailored manufacturing capabilities are critical in a CDMO. But, when you’re sprinting to market with a niche product, a partner who can also source your raw materials and de-risk your regulatory pathway is everything. With the right partner, every point along the development and manufacturing value chain journey becomes accelerated.

Finding the Right CDMO for Your Niche Drug Project

Through advanced technology, deep industry knowledge and an unwaveringly collaborative approach, our proven capabilities help life sciences companies succeed in a highly competitive and complex marketplace from targeted biologics to cybersecurity. 

Imagine, Evolve, Improve

Partner Smart with End-to-End CDMO. What if you could rely on one partner to source APIs, formulate and develop drug products, and manufacture at clinical and commercial scale? Rather than too many links in your supply chain, an end-to-end CDMO reduces layers of administration, gaps in knowledge, time, cost, and risk. 

Five “Must Ask” Questions to Find the Right CDMO  

Cybersecurity with Clarity and Rockwell Automation 

How Life Sciences Organizations Can Fast-Track Industrial Cybersecurity

Get ahead of cyber-attacks by keeping pace with the speed of IIoT innovation

A Proactive Approach to Cybersecurity

Optimizing API Procurement. Supply chain woes existed long before the pandemic, and not many scientists want to spend time sourcing ingredients. There is a way to ensure you get the right active pharmaceutical ingredients, at the right cost, with the right plan to scale: partnering with an API procurement and supply chain specialist. 

Five Reasons to Outsource API Procurement (Mar 2023)

 Biotech, BioPharma’s, CDMOs, CROs who are investigating promising nucleic acid-based drug candidates like vaccines, mAbs, and other biologics & biosimilars must go through stringent quality control checks for their molecular entities to ensure safety & efficacy of their drug candidates. Explore the best quality control workflows using QualTrak qPCR ecosystems. Learn more inside this eBook about the benefits of:


Real-Time PCR & Digital PCR in QC of Biopharmaceutical Discovery & Development

WuXi Sta outlines clear guidance on phase appropriate RSM designation and adaptive RSM strategy for the overall API development roadmap. These solutions will mitigate both quality and regulatory risks, thus increasing the chance of success in IND and NDA filing.

Establishing and Maintaining Phase-Appropriate Regulatory Starting Materials Designation from Development to Commercial Launch Secures Successful New Drug Development 

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