Chembio Diagnostics Leverages ThinkTrends’ Generative AI to Streamline IVDR Submissions for Global Regulatory Compliance

Herndon, VA – August 14, 2024 – Chembio Diagnostics Inc., a BioSynex Group company and global leader in in-vitro diagnostics, has successfully partnered with ThinkTrends, a provider of no-code Generative AI solutions, to optimize its regulatory operations and streamline preparation for upcoming In Vitro Diagnostic Regulation (IVDR) submissions. This strategic collaboration enables Chembio to leverage past submission data, regulatory research, and device documentation to prepare robust, efficient, and compliant regulatory submissions to European (EMA) and U.S. (FDA) authorities for 2026 and beyond.

The IVDR (EU Regulation 2017/746), enacted in 2017, imposes comprehensive requirements for diagnostic device manufacturers, including detailed documentation, scientific validation, and regulatory conformity assessments. For companies like Chembio, preparing an IVDR submission involves hundreds of pages of regulatory writing, trial data, and supporting documentation, a process that can take 4 to 6 months per submission.

To ensure that future submissions are both efficient and fully compliant, Chembio adopted ThinkChat, ThinkTrends’ no-code Generative AI platform, which was custom-trained on Chembio’s internal documents, past submissions, research data, device labels, and public regulatory information, including IVDR. This solution enables Chembio’s regulatory affairs team to generate insights, cross-reference regulations, and streamline documentation development with unprecedented speed and precision.

The new partnership with ThinkTrends marked a pivotal step toward future-proofing compliance processes under the IVDR framework.

The Citation Generation feature in ThinkChat is very precise and detailed. Our team was quickly able to pinpoint the regulations and their sections. We enjoy working with the ThinkTrends team. They are detail-oriented, pay close attention to our requirements and needs, and work diligently in custom tailoring the AI models. Tom Ippolito, Vice President, Quality and Regulatory Affairs, Chembio Diagnostics Inc.

By implementing ThinkChat, Chembio now has a dynamic knowledge base that integrates internal and public regulatory data, allowing teams to search, analyze, and generate draft submission content in real-time. ThinkChat’s source-backed responses include direct links to regulations, page-specific citations, and confidence scores, enabling teams to ensure compliance and accuracy at every step of the submission process.

Empowering our clients in the healthcare and diagnostics sectors to meet and exceed the demands of complex regulations like IVDR is central to our mission. ThinkChat allows teams to leverage their own data, learn from past submissions, and generate future-ready documentation with confidence and agility. Jyotiska Biswas, CEO, ThinkTrends

Beyond content generation, ThinkChat enhances collaboration and consistency through shared workspaces, document refinement tools, integrations, and regulatory databases. Chembio’s teams can now co-create documentation, refine reports, and adapt submissions to evolving standards, ensuring their next IVDR submission is more efficient, data-driven, and compliant.

About ThinkTrends

ThinkTrends delivers secure, no-code Generative AI and RPA solutions for biopharma, life sciences, and regulatory agencies, helping organizations streamline data workflows and regulatory compliance without technical barriers. With AI platforms like ThinkChat, ThinkTrends enables teams to unlock actionable insights from unstructured data and navigate complex regulations with ease.

For more information about ThinkTrends and its AI solutions, visit www.thinktrends.co

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