Frequently Asked Questions
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General Questions

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1. What is eCTD, and why is it important for regulatory submissions?
eCTD (Electronic Common Technical Document) is the global standard for electronic regulatory submissions to agencies like the FDA, EMA, and MHRA. It streamlines dossier management, improves review efficiency, and ensures compliance with health authority requirements.

 

2. What types of regulatory submissions does eCTD Pharma handle?
We specialize in eCTD publishing, lifecycle management, and global regulatory submissions, including:

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• FDA submissions (IND, NDA, ANDA, DMF, BLA)

• EMA & MHRA submissions (MAA, variations, renewals)

• Rest of World (ROW) & NeeS submissions

• Clinical Trial Applications (CTA)

• Biologics and biosimilar submissions

• FDA Publishing: Specialized support for electronic submissions to the U.S. Food and Drug Administration (FDA).

• EMA Publishing: Expert assistance with electronic submissions to the European Medicines Agency (EMA).

• ROW and NeeS Publishing: Services for Rest of World (ROW) markets and Non-eCTD electronic Submissions (NeeS).

• Document Preparation: Professional preparation of regulatory documents to ensure compliance and accuracy.

• Investigator Submissions: Support for submissions initiated by investigators, including clinical trial applications.

• Investigational New Drug (IND) Applications: Comprehensive services for preparing and submitting INDs.

• New Drug Application (NDA): Assistance with the preparation and submission of NDAs for new drug approvals.

• Abbreviated New Drug Application (ANDA): Support for generic drug applications through ANDA submissions.

• Marketing Authorization Application (MAA): Expertise in preparing and submitting MAAs for market authorization.

• Biologics License Application (BLA): Services for the preparation and submission of BLAs for biologic products.

• Clinical Trial Application (CTA): Support for the preparation and submission of CTAs to conduct clinical trials.

• Drug Master File (DMF): Assistance with the preparation and submission of DMFs to regulatory authorities.

• With over 40 years of eCTD management experience and more than 5,000 successful submissions, eCTD Pharma is well-equipped to handle your regulatory needs

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3. Which regulatory agencies accept eCTD submissions?
We support eCTD submissions to the FDA (U.S.), EMA (Europe), MHRA (UK), Health Canada, TGA (Australia), PMDA (Japan), and other global regulatory authorities.

 

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eCTD Publishing & Submission Services

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4. What is the eCTD submission process?
The eCTD submission process involves dossier compilation, document formatting, hyperlinking, validation, and electronic submission through the relevant health authority’s portal.

 

5. Can you convert legacy submissions to eCTD format?
Yes. We provide legacy submission conversion services, ensuring compliance with current eCTD standards for smooth regulatory approvals.

 

6. How do you ensure eCTD compliance and validation?
We use industry-leading eCTD validation tools to check technical compliance, avoiding errors that could lead to rejection by regulatory authorities.

 

7. What are lifecycle management submissions?
Lifecycle submissions cover post-approval changes, such as variations, amendments, renewals, and annual reports, ensuring continued regulatory compliance.

 

8. How long does the eCTD submission process take?
Timelines depend on submission type and regulatory requirements, but we prioritize fast turnaround times while maintaining compliance.
 

9. What is a Drug Master File (DMF), and do I need one?
A DMF provides confidential information about drug substances or excipients to regulatory agencies. We assist with DMF preparation and submission to streamline approvals.

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10. What are the differences between NDA, ANDA, and BLA submissions?

• NDA (New Drug Application): For new, innovative drugs.

• ANDA (Abbreviated New Drug Application): For generic drug approval (bioequivalence required).

• BLA (Biologics License Application): For biologics and biosimilars.

 

11. Do you offer regulatory strategy consulting?
Yes, we provide regulatory strategy development, including gap analysis, submission planning, and compliance assessments.

 

12. What is a Clinical Trial Application (CTA)?
A CTA is required to obtain regulatory approval to conduct clinical trials. We assist with CTA preparation and submissions worldwide.

 

13. What happens if my submission is rejected?
If a submission is rejected, we conduct a comprehensive review, address deficiencies, and resubmit to meet regulatory expectations.

Technical & Document Preparation
 

14. What is NeeS, and how does it differ from eCTD?
NeeS (Non-eCTD electronic Submission) is an older format used in some regions. We provide NeeS-to-eCTD conversion for agencies transitioning to eCTD requirements.

 

15. Do you provide hyperlinking and bookmarking for eCTD documents?
Yes, we ensure all regulatory documents are properly formatted, hyperlinked, and bookmarked for easy navigation by reviewers.

 

16. Can you help with Structured Product Labeling (SPL) submissions?
Yes, we offer SPL preparation and submission services to ensure compliance with FDA requirements for drug labeling.
 

17. How do eCTD requirements differ between the FDA, EMA, and other agencies?
While ICH eCTD standards are globally recognized, each agency has unique submission requirements. We ensure your dossiers meet regional specifications.

 

18. What are the latest changes in eCTD regulations?
Regulatory agencies frequently update eCTD guidelines. We stay updated with changes and advise clients on compliance requirements.

 

19. Do you provide training on eCTD submissions and regulatory compliance?
Yes, we offer eCTD training and workshops to help pharmaceutical companies understand regulatory requirements and submission best practices.

 

20. How can I get started with eCTD Pharma’s services?
Contact us to book a consultation, and we’ll guide you through the regulatory submission process, ensuring full compliance and efficiency.