eCTD compilation Life cycle Management:

Initial eCTD Preparation:

Strategic Planning:

  • We work closely with you to develop a strategic plan for the creation and organization of eCTD submissions.
  • Our experts ensure that your submission strategy aligns with regulatory requirements and submission goals.

Document Conversion:

  • ERA assists in converting your existing documentation into the eCTD format, including documents from various sources and formats.
  • We employ advanced software tools and quality control measures to ensure data accuracy and compliance.

eCTD Submission:

Compilation and Validation:

  • Our team compiles and validates eCTD submissions, ensuring that all documents are properly formatted, hyperlinked, and meet regulatory guidelines.
  • ERA conducts rigorous validation checks to minimize submission errors and rejections.

Submission Planning:

  • We plan and execute the electronic submission process, coordinating with regulatory authorities to ensure successful submission and tracking.
  • Our experts facilitate electronic transmission to regulatory agencies as per their requirements.

eCTD Life Cycle Maintenance:

Post-Submission Support:

  • ERA provides ongoing support for post-submission activities, including managing queries and responses from regulatory agencies.
  • We ensure timely updates to eCTD submissions, including variations, renewals, and post-approval changes.

By entrusting ERA with your eCTD life cycle management, you gain a partner dedicated to streamlining your electronic regulatory submissions. Our commitment to strategic planning, precise execution, and continuous compliance ensures that your eCTD submissions are efficient, error-free from technical perspective and maintain compliance throughout the product lifecycle.