SERVICES
eCTD Publishing
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.
eCTD MS WORD & PDF FORMATTING
When publishing PDF files, it is important to consider the MS Word and PDF specifications guidance. These best practices come from recommendations from the ICH, We take great care of guidance on PDF specifications when publishing PDF files, in order to meet the maximum efficiency for every submission.
PDF PUBLISHING
We take great care to follow industry guidance on PDF specifications when publishing PDF files, in order to meet the maximum efficiency for every submission. These best practices come from recommendations by the ICH and regional regulatory authority, and are essential for a successful submission that avoids technical rejection. By adhering to these standards, we can ensure that our PDF files meet the highest quality standards.
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.
eCTD Submissions Management Services
Regulatory submission management can be a complex process, we manage the complex and make it simple. We wholly manage the eCTD process, from start to finish, maintaining a complete overview of the submission across multiple lifecycle stages and to global regulatory health authorities.
MS WORD FORMATTING
Any document that is being prepared for eCTD submission must be formatted correctly. Ensuring margins, font sizes, cross referencing, tables are present. Without a pre-defined Word template to work from, this can be a very time-consuming task. At Zenith Consultancy, we have years of experience formatting MS Word documents for eCTD submission.