KEY TAKEAWAYS
- Generating regulatory content is complex and organizations are struggling to keep pace with the volume of data
- Automation tools are rapidly popping up in the market, making it difficult for the industry to sift through and evaluate the quality of these tools – not all AI is made equally
- Organizations are seeking tailored NLP & NLG tools to manage large volumes of complex information, enhance collaboration, and ensure accuracy and compliance in critical documents
- Structured authoring, combined with AI technologies, can be a key tool in creating and managing this complex documentation
What You Need to Know:
Glemser Technologies is an experienced partner to life sciences organizations. Glemser provides artificial intelligence (AI) powered structured content authoring solutions to accelerate the regulatory content generation process. Glemser leverages AI-powered natural language models and pre-configured health authority outputs to accomplish this reduction in content generation timelines.
Representatives from Glemser attended the Proventa International hosted Regulatory Affairs Strategy Conference in Cambridge, MA. They brought together industry and vendor stakeholders working across the scope of regulatory affairs to dive deeper into current challenges and evolving solutions. Many of the discussions centered around how using AI can align people, process, and technology to improve cycle times and quality. The forum presented five tracks:
- RIM and Data Management
- Regulatory Operations & Regulatory Strategy
- Labeling, Artwork, and regulatory Content Management
- Regulatory Submissions / ECTD
- Compliance
Jamie Morisco, Director of Sales, Glemser Technologies and Pawan Gandhi, Director of R&D at Glemser Technologies presented at Proventa, showcasing how their product, ComplianceAuthor™ leverages artificial intelligence can reduce the timeline to generate regulatory content by up to 50%. The software solution demonstrated that ComplianceAuthor™ is pre-configured for Life Sciences and optimizes the content generation process for Global Labeling, CMC, Clinical Labeling, and other additional use cases.
Key Takeaways: Empowering Regulatory Affairs with AI Solutions
Organizations are evaluating technology to help resolve or mitigate challenges. The appetite for technology and automation has increased with the widespread use of tools like ChatGPT. Industry attendees were focused on how to ensure they are finding and evaluating the right tools that are primed for life sciences and the complex industry use cases and compliance requirements.
It’s important that service and solution providers be flexible and ready to meet these organizations where they are along the journey of automation. Whether an organization is in Phase 1 of a clinical trial or creating global labels for dozens of products, automation can have a material impact on each process and scale to meet their evolving needs.
Automation will be required for organizations that want to remain competitive in the industry. Glemser’s ComplianceAuthor™ is an automation-powered structured content authoring tool that was designed for life sciences, meets regulatory requirements, and takes the hard work out of keeping pace with a rapidly evolving industry.
Whether you’re just starting your automation journey or already well on your way, Glemser Technologies is eager to learn more about your unique needs and challenges. We strive to understand your specific requirements to help best reach your specific organization’s goals. Reach out to us at inquiry@glemser.com, and let’s explore how we can assist you in optimizing your regulatory affairs processes with AI-powered structured content authoring for life sciences.
