IDBS and Alchemi Partner to Accelerate AI-Driven Regulatory Submissions in Biopharma

18 June 2026 | Thursday | News

Integration of Alchemi’s AI agents with the IDBS Polar platform enables faster generation of compliant regulatory documents while maintaining traceability auditability and human oversight across the drug development lifecycle.

IDBS, a Danaher company and leading provider of cloud software for biopharma, and Alchemi, a leading applied AI company serving the world's largest pharma and biotech development teams, today announced a partnership connecting AI agents to data captured and contextualized in the IDBS Polar platform across the drug development lifecycle.

Preparing regulatory filings remains one of biopharma's most persistent bottlenecks. CMC teams spend months assembling data, drafting reports and reconstructing process histories, while current AI tools often break the compliance chain by pulling data out of validated systems.

Connecting Alchemi's purpose-built agents to Polar's trusted, AI-ready data foundation keeps validated data traceable and auditable. CMC technical reports, clinical study reports and submission dossiers can be drafted faster and routed through human-in-the-loop workflows for review and sign-off, maintaining compliance. According to Alchemi, in customer deployments across biopharma, teams have produced documents of this type up to 70% faster using its agents.

IDBS Polar powers the Lab Loop—from experiment execution, through data aggregation, to insights that drive decisions. By capturing structured, contextualized data at the point of creation within a single governed backbone, Polar delivers the data foundation that makes agentic AI viable in regulated environments.

Alchemi's agents draw on Polar's governed data to draft these reports and dossiers, then route each draft to a scientist for review and sign-off. Each human and AI action is captured in a 21 CFR Part 11 audit trail, so the work stays compliant from source to submission.

AI agents are only as good as the data they act on. This partnership ensures biopharma teams get both: governed data from Polar and purpose-built intelligence from Alchemi.

"A regulatory filing that takes a team weeks, our agents draft in minutes, at submission-ready quality, with the compliance trail intact, because they work straight from governed data in Polar. That's the difference between AI you can demo and AI you can take to submission," said Anuj Chadha, Co-Founder, Alchemi.

"Our mission is to accelerate life-changing therapies to patients, and as part of Danaher, that means turning ideas into impact with speed and certainty. IDBS delivers a governed data backbone that makes AI-ready data available across the biopharma lifecycle. By partnering with Alchemi, we can accelerate critical regulatory milestones using high-quality, compliant AI agents," said Pietro Forgione, General Manager, IDBS.

 

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