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      IDBS and Alchemi partner to accelerate biopharma regulatory filings with compliant AI agents

      IDBS-Alchemi

      News provided by

      IDBS

      Jun 16, 2026, 10:13 ET

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      NEW YORK and WOKING, England, June 16, 2026 /PRNewswire/ -- 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.

      About IDBS

      IDBS, a Danaher company, helps biopharma organizations turn scientific data into trusted insight that accelerates innovation and improves patient outcomes. A long-term partner to 75% of the top 20 global biopharma companies¹, we bring 35 years of scientific informatics expertise to deliver cloud software and services that connect data, workflows and teams across the product lifecycle from R&D through manufacturing.

      The IDBS Polar platform powers the Lab Loop, from experiment execution through data aggregation to the insights that drive decisions. By capturing structured, contextualized data at the point of creation, Polar delivers an AI-ready data foundation for advanced analytics and agentic AI across both GxP and non-GxP environments. IDBS PIMS extends this capability into manufacturing with process insight for batch monitoring, continued process verification and regulatory reporting support.

      As part of Danaher, IDBS combines deep domain expertise with continuous innovation to help customers solve complex scientific challenges and turn insight into impact at global scale.

      Visit idbs.com to learn more about IDBS.

      IDBS is proud to be part of Danaher. Visit www.Danaher.com to learn more about Danaher, a leading life sciences and diagnostics innovator committed to accelerating the power of science and technology to improve human health.

      1. Rank measured by Market Cap, Q2 2026.

      About Alchemi

      Alchemi builds AI agents that accelerate drug development, compressing work that takes scientists weeks into minutes. Its agents work across the development lifecycle, from non-clinical and clinical through CMC, regulatory submissions and post-marketing. They draft and review documents, analyze and quality-check data, and streamline safety and manufacturing workflows, all from governed data and routed through human review.

      Each agent is built by Alchemi scientists and AI engineers working side by side and tailored to each customer's unique workflows and standards, rather than a one-size-fits-all approach. Every AI and human action is captured in full 21 CFR Part 11 audit trails, so speed never breaks the compliance chain.

      Founded in 2024 and headquartered in New York, Alchemi will deliver at least 3,000 studies this year with top-five global CROs, large pharma and biotech. Alchemi is on a mission to get life-changing therapies to patients faster.

      Learn more at www.alchemi.bio.

      MEDIA ENQUIRIES

      IDBS:
      e |  [email protected] 

      Alchemi:

       e | [email protected]

      SOURCE IDBS

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