Electronic Common Technical Document Compilation

Streamline Regulatory Complexities and Accelerate Market Approval with Zenovel’s Expert eCTD Solutions.

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 eCTDsubmission 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 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.

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

We specialize in compiling eCTD to meet stringent requirements of international health authorities.

Our team is proficient in global eCTD publication trends and regulatory requirements.

From initial consultation to submission support, we offer a detailed, end-to-end service

We provide personalized plans tailored to your specific needs

Reach out to us for any inquiries or support needs.

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Zenovel, your trusted partner for Regulatory Compliance and Clinical Research Quality Assurance

GCP

Zenovel, your trusted partner for Regulatory Compliance and Clinical Research Quality Assurance

Pre Submission Service

Dossiers Related Services

Submission Services

Post Submission Services

Batch Release & Testing Services

Support & Staffing Services

RA Services

AI-powered Regulatory Affairs Services

Zenovel, your trusted partner for Regulatory Compliance and Clinical Research Quality Assurance

Zenovel, your trusted partner for Regulatory Compliance and Clinical Research Quality Assurance

Electronic Common Technical Document Compilation

We streamlined your regulatory submission with expert eCTD compilation

Health Authority

Application & Submission document required

USFDA Food and Drug Administration

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 Expertise

Health Authority

Application & Submission document required

USFDA Food and Drug Administration

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

Blogs and news

Our Latest Article

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