CAMBRIDGE, Mass. and CAMBRIDGE, England, May 11, 2026 /PRNewswire/ -- Zifo announced today that 7 of the world's top 15 biopharma companies have adopted its Chemistry, Manufacturing, and Controls (CMC) services, as the company pursues its mission to meet customer demands for a 50% reduction in execution timelines and solve one of the industry's most persistent bottlenecks: moving new therapies from development into regulated manufacturing and patient trials.
Pharma and Biotech industries are very efficient at early-stage research. However, transitioning those discoveries into clinical trials remains a severe bottleneck as the CMC process is currently very time-consuming and complex with estimates anywhere between 18-36 months.
Every new therapy must undergo the CMC phase. To achieve this, companies must conduct extensive analytical testing and experimentation, then synthesize a vast amount of complex data -- ranging from manufacturing process controls and stability parameters to a deep understanding of analytical test variance.
Hence, navigating the CMC landscape requires a unique blend of deep science, data management, and organizational empathy; Zifo's mastery of Science, Technology, Data, AI, Change Management, and automation stands as a testament to its leadership in the field.
"Think of the CMC process like a really narrow funnel," said Paul Denny-Gouldson, Chief Scientific Officer, at Zifo. "You have all this wide-open scientific discovery and development, and then the process slows and becomes very sequential. Executing all the process steps, testing and process evaluations and then pulling all that data from disconnected lab systems into regulatory documentation is painfully slow and currently a very manual process. Our work with our customers is revolutionising the way CMC is thought of, executed and managed".
And this is where Zifo's Practical AI Blueprints come into play during the CMC stage. Instead of relying on unpredictable, 'black box' AI models, Zifo uses targeted AI to do the heavy lifting of data structuring. The models automatically pull and map unstructured CMC data from different source documents, turning it into standardized, audit-ready formats. It takes the administrative burden off the scientists, drastically cuts down on manual transcription errors, and ensures the data is ready for FDA and EMA submissions.
It's an approach that solves very different problems for scientific and technology leaders.
For Scientists, the benefit is trust. Because over 90% of Zifo's experts have a scientific background, research teams know their data will maintain strict regulatory compliance during the transfer. They can get back to focusing on the pipeline instead of fighting with paperwork.
For IT teams, it's about reducing technical debt whilst enabling better science without compromising quality. Zifo's strategy looks to leverage current systems where possible, limiting the need for a massive, ground-up overhaul. Plus, with a global and local delivery model, Zifo provides the 24/7 support needed to take this CMC transformation from idea to production in previously unimaginable speed -- meaning faster time to value and outcomes for the business.
"At the end of the day, our clients are making life-saving drugs. They can't afford to get stuck in a historical lab execution, data, and informatics traffic jam during the critical CMC stage," added Paul. "We just want to make sure scientists can work so much faster than today and where data flows safely and securely from the lab to the regulatory submissions and internal tech transfer teams to meet those 50% reduction in CMC timelines".
For more information on Zifo's CMC Services, visit https://zifornd.com/services/cmc-services-manufacturing/.
About Zifo
Zifo is the leading global enabler of AI and data driven enterprise informatics for science driven organizations. With extensive solutions and services expertise spanning research, development, manufacturing, and clinical domains, we serve a diverse range of industries, including Pharma, Biotech, Chemicals, Food and Beverage, Oil & Gas, and FMCG. Trusted by over 190 science-focused organizations worldwide, Zifo is the partner of choice for advancing digital scientific innovation. https://zifornd.com/; https://zifornd.com/services/cmc-services-manufacturing/; https://zifornd.com/practical-ai-blueprints/
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