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DIA Regulatory Submissions, Information, & Document Management Forum

What You Need to Know

Navitas Life Sciences, a leading provider of technology enabled services to life science companies, partnered with Glemser Technologies to bring innovations and technology advancements in global labeling to the life science industry. Representatives from each company attended the DIA Regulatory Submissions, Information, and Document Management Forum. The event brought together industry and regulatory stakeholders working across the scope of regulatory information to examine current and evolving data standards and requirements and effective regulatory information management approaches to align related people, processes, and technology. The forum presented four tracks:

  • Regulatory Information Business
  • Regulatory Informatics Technology
  • Trial Master File (TMD) Inspection Readiness and Electronic Document Management
  • Electronic Regulatory Submissions

Govind Srinivasan, Sr. Vice President, Business Partner Regulatory and Safety Technology attended the conference and met with participants who were keen on learning more about our support.

Here are Govind’s Key Takeaways from DIA:

  • The FDA, EMA, and other countries regulators are pursuing programs to promote automation within the agencies and within the industry. Agencies are at different stages with initiatives to make submission processing automated and structured.
    • This in turn will increase the expectations from the agencies on the industry to improve the level of compliance by tracking all internal processes and by adopting newer technologies including the structured content and higher level of data standardization & management.
  • Industry participants want to automate their content management, RIM and labeling using latest technologies like RPA, AI/ML and NLP, & NLG.
    • Require integrated end-to-end solutions like labelReady & ComplianceAuthor™ which are pre-configured for life sciences
    • Navitas and Gelmser partnership brings this first of kind technology to the industry in structured content and label change management tracking
    • We firmly believe that label content management and changes tracking will be easier for companies selling products in multiple geographies across the globe

Jamie Morisco, Director of Sales, Glemser Technologies presented at DIA, showcasing how natural language processing can reduce the timeline to generate a submission ready label by up to 50%. He spoke about the availability of Life Sciences specific tools that are available in the market and pre-configured to add value immediately and improve the label generation process.

Here are Jamie’s Key Takeaways from DIA:

Both life sciences organizations and regulatory agencies spoke about the need for automation to assist in processing and maximizing value from their structured and unstructured data. The market requires a solution that is flexible, scalable, and pre-configured for life sciences use cases. Whether it is global labeling, clinical labeling, CMC, clinical study reports, medical/scientific writing, or any other use case, clients need to store data as components for use and re-use. Glemser takes an innovative approach and leverages life sciences tailored NLP, NLG, and SCM tools to render Word, XML, JSON, HL7 FHIR, IDMP, document, and regulatory outputs. Using these advancements, the document and label generation timeline can be reduced by half while sustaining the appropriate controls, compliance, and quality standards.

Life Sciences companies are feverishly pursuing options that enable them to get life-saving drugs to market as quickly as possible. The current labeling process is complex, at risk for manual error, compliance violations, patient safety risk and can take over 12 months. Glemser & Navitas’ technology enabled process optimization positions organizations to meet regulatory requirements and keep pace with a rapidly evolving industry.

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