REGULATORY ADVISORY SERVICES

To ensure eCTD submissions are compliant with all of the relevant regulations, it is important to work with a submission expert who has experience with eCTD formats. At ONIX, we help our clients navigate the eCTD submission process ensuring our clients submissions are compliant with all relevant regulations and are set up for success for ongoing lifecycle maintenance.
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eCTD CONSULTANCY

eCTD requirements can be difficult to navigate and we are here to help our clients every step of the way to understand this process. Our typical consultancy engagement includes:
  • Overall strategy for eCTD applications
  • eCTD metadata
  • Document compliance
  • Granularity of eCTD documents
  • Requirements for regional regulatory health authorities

We work with our clients to provide best practice guidance on the way to prepare and submit eCTD applications and answer any questions they may have. Our services are tailored to each client, and we work with them to ensure their eCTD submissions are compliant with all applicable regulations.

GAP ANALYSIS

We offer a comprehensive assessment of our clients’ documents and current processes to ensure they are aligned with the eCTD requirements of regulatory authorities. We provide guidance on how to create eCTD compliant documents. This allows our clients to stay compliant with the latest regulatory requirements and improve their overall efficiency.
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Regulatory Advisory Service

TRAINING

Our regulatory operations training services are designed to assist clients in formatting Microsoft Word and PDF documents in preparation for eCTD submissions. In our training workshops, we guide our clients with industry best practices to ensure documents are submission-ready and troubleshoot any issues.
Our clients often ask us questions about eCTD compliance and submission requirements. Frequently asked questions include:

What is an eCTD?

What is eCTD metadata?

What are the benefits of eCTD submissions?

What are the requirements for eCTD submissions?

How do I prepare documents for an eCTD submission?

How do I know if my submission is compliant?

What is the timeline for eCTD submissions?

How much does an eCTD submission cost?

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