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

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