eCTD compilation Life cycle Management:
Initial eCTD Preparation:
- 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.
- 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.
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.
- 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:
- 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.