Regulatory

Speed Time to Market with eTMF and eCTD

Technology-based interactions between life sciences firms, external partners and regulatory agencies, such as eTMF and eCTD, 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 eTMF and eCTD Expertise

The Daelight team has more than 100 years of combined experience helping Tier 1, 2 and 3 life sciences organizations more effectively interface with regulatory bodies. We’ve worked with all leading submission, publishing and registration solutions, including:

  • Veeva Vault eTMF
  • MasterControl
  • SureClinical eTMF
  • cune-ECTD
  • QUMAS
  • pharmaREADY