Electronic Common Technical Document Compilation
Streamline Regulatory Complexities and Accelerate Market Approval with Zenovel’s Expert eCTD compilation services.
We streamlined your regulatory submission with expert eCTD compilation
The European Medicines Agency (EMA), the US FDA, and other Health Authorities worldwide accept electronic Common Technical Document (eCTD) submissions for applications, amendments, supplements, and reports. eCTD submissions allow for quick creation and review of data, including bookmarks, hyperlinks, and metatags. This facilitates efficient evaluation and successful lifecycle management of eCTD submissions, resulting in faster market approvals and authorizations.
Zenovel manages dossier filing across multiple countries and understands global eCTD publication trends. We offer professional eCTD compilation services to ensure compliance with international regulatory requirements and streamline the submission process, addressing the difficulties and exacting specifications associated with regulatory filings.
The specifications used by Global eCTD submission services
- The specifications used by Global eCTD submission services
Health Authority
Application & Submission document required
USFDA Food and Drug Administration
The document lists various types of submissions for new drugs, including Investigational New Drug (IND), New Drug Application (NDA), ANDA, Biological License Application (BLA), Over-the-Counter (OTC), Drug Master Files (DMF), Structured Product Labeling (SPL), and Supplemental New Drug Application (SNDA), as well as originals, amendments, annual reports, and eCTD submissions.
European Medicine Agency
Centralized, decentralized, mutual recognition, and national aspects, as well as clinical trial applications, originals, variations, atoqs, renewals, ASMF eCTD submissions, and medical device submissions.
Health Canada
The document outlines the different types of New Drug Submissions, including NDS, SNDS, SNDS-C, ANDS, and SANDS, as well as their respective supplements.
Australian Therapeutic Goods Administration
Market Authorization Applications
- Our Process
Our Expertise
- Documenting regional Health Authority requirements
- Converting paper to non-eCTD electronic submissions
- Developing a global knowledge repository.
- Regular training and updates on global eCTD publishing and submission requirements are provided.
- Gap analysis is used to create process aids and charts
- Continuous project monitoring is conducted, and
- Quality checks are conducted for effective time management.
- The specifications used by Global eCTD submission services
Health Authority
Application & Submission document required
USFDA Food and Drug Administration
The document lists various types of submissions for new drugs, including Investigational New Drug (IND), New Drug Application (NDA), ANDA, Biological License Application (BLA), Over-the-Counter (OTC), Drug Master Files (DMF), Structured Product Labeling (SPL), and Supplemental New Drug Application (SNDA), as well as originals, amendments, annual reports, and eCTD submissions.
European Medicine Agency
Centralized, decentralized, mutual recognition, and national aspects, as well as clinical trial applications, originals, variations, atoqs, renewals, ASMF eCTD submissions, and medical device submissions.
Health Canada
The document outlines the different types of New Drug Submissions, including NDS, SNDS, SNDS-C, ANDS, and SANDS, as well as their respective supplements.
Australian Therapeutic Goods Administration
Market Authorization Applications
- Why Choose Zenovel ?
- Sleek Regulatory Process
We specialize in eCTD compilation to meet stringent requirements of international health authorities.
- Efficient Team
Our team is proficient in global eCTD publication trends and regulatory affairs requirements.
- Comprehensive Process
From initial consultation to submission support, we offer a detailed, end-to-end service
- Tailored Solutions
We provide personalized plans tailored to your specific needs
People Also Ask (FAQs)
eCTD compilation refers to the process of organizing and formatting regulatory submission documents into the Electronic Common Technical Document (eCTD) structure required by global regulatory authorities. This format ensures that pharmaceutical product dossiers are submitted electronically with standardized folder structures, hyperlinks, and metadata.
eCTD compilation ensures that regulatory documents are properly structured according to international submission standards required by health authorities. A well-prepared electronic dossier improves document navigation, facilitates faster regulatory review, and reduces the risk of submission errors or validation issues. Zenovel supports this process by providing expert eCTD compilation services, ensuring accurate formatting, technical compliance, and submission-ready dossiers aligned with global regulatory requirements.
An eCTD submission typically includes the five modules of the Common Technical Document (CTD): administrative information, summaries, quality documentation, non-clinical data, and clinical study reports. These documents are compiled electronically with hyperlinks, bookmarks, and XML backbone files to meet regulatory submission standards.
Zenovel provides comprehensive eCTD compilation and publishing services, ensuring that regulatory documents are correctly structured, validated, and submission-ready. Their experts assist with CTD to eCTD conversion, lifecycle management, hyperlinking, bookmarking, and regulatory compliance, helping pharmaceutical companies meet global electronic submission requirements.
Many global regulatory agencies require submissions in Electronic Common Technical Document (eCTD) format, including authorities such as the U.S. Food and Drug Administration, the European Medicines Agency, and other international health authorities. Using the eCTD format ensures standardized electronic submission and improves efficiency in regulatory review processes.
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