Regulatory

Speed Time to Global Markets with Regulatory Information Management

Technology-based interactions between life sciences firms, external partners and regulatory agencies have created tremendous opportunities to eliminate manual processes and speed overall submission timelines. Unfortunately, they’re also fraught with possibilities for mistakes and inefficiency. Daelight can help.

Streamline Submissions & Ensure Compliance

Whether your pharmaceutical, biotech or medical device firm is just transitioning from paper-based processes or has been delivering trial master files and common technical documents electronically for years, our team can help you streamline your information gathering, organization and submission activities.

Daelight’s proven methodologies and experienced consultants have helped organizations large and small:

  • Move away from paper-based submissions in accordance with established best practices
  • Ensure the accuracy, completeness and organization of essential documentation
  • Integrate systems of record and CTMS with eTMF and eCTD solutions
  • Stay up to date (and in compliance) with the latest health authority guidance on electronic submissions
  • Standardize conventions and eliminate duplicate documentation
  • Eliminate error-prone manual processes by automating workflows
  • Streamline quality control and audit efforts

Our Regulatory Expertise

The Daelight team has proven abilities to guide projects from concept to conclusion. Our experienced team not only offers technical expertise in solutions designed to optimize Regulatory Information Management (RIM) functions but also has a firm grasp on the business processes for which they support. We’ve worked with all leading registration, submission content management, publishing, archiving and registration solutions, including:

  • Veeva Vault RIM
  • cune-ECTD
  • Parexel Insight
  • OpenText LSRD