Byet ElKhebra ElDwaea
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Product Registration in Egypt
  • Pharmaceutical Products Registration
  • Biological & Biosimilar Registration
  • Medical Devices & IVD Registration
  • Cosmetics Registration
  • Food Supplements Registration
  • Disinfectants & Antiseptics Registration
Regulatory Submissions (CTD & eCTD)
  • CTD Dossier Preparation
  • eCTD Publishing & Submission
Quality & Compliance
  • Quality Management System (QMS)
  • GSDP Certification for Warehouses
  • QMS for Pharmacovigilance Offices
  • Audit & Compliance Readiness
Pharmacovigilance
  • Pharmacovigilance Services
  • Medical Device Vigilance (Materiovigilance)
Training & Regulatory Consulting
  • Regulatory Affairs Consulting
  • Regulatory Affairs Training
  • CTD & eCTD Practical Training
  • GSDP & Quality Systems Training
Training & ProgramsRegulatory Intelligence CenterContact UsRegulatory Science Framework™
Byet ElKhebra ElDwaea

Your trusted partner for pharmaceutical regulatory affairs, product registration, quality systems, and regulatory consulting in Egypt and across the Arab region.

ISO 9001:2015 Certified · EGAC | IAF

Services

  • Product Registration in Egypt
  • Regulatory Submissions (CTD & eCTD)
  • Quality & Compliance
  • Pharmacovigilance
  • Training & Regulatory Consulting

Get In Touch

  • 29 El-Ekhshid St., opposite El-Ekhshid Grand Mosque, Manial El-Rouda, Giza, Egypt 11555

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Regulatory Submissions

Regulatory Submissions (CTD & eCTD)

Byet El Khebra provides professional CTD dossier preparation, eCTD publishing, submission readiness, validation, and lifecycle management — supporting pharmaceutical, biotechnology, and biosimilar organizations across Egypt, the GCC, the MENA region, Europe, Africa, and international markets.

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CTD Dossier Preparation
CTD Review & Gap Analysis
eCTD Readiness
eCTD Publishing
Extedo Software Support
Validation & Lifecycle Management

Our CTD & eCTD Services

  1. 1CTD Dossier Preparation — Preparation and organization of Common Technical Document dossiers per international requirements.
  2. 2CTD Review & Quality Assessment — Comprehensive review to identify gaps, inconsistencies, compliance issues, and submission risks.
  3. 3CTD Gap Analysis — Assessment of dossier completeness and identification of missing information prior to submission.
  4. 4Submission Readiness Assessment — Evaluation of documentation, structure, and overall readiness before regulatory filing.
  5. 5CTD Remediation Support — Improving dossier quality, addressing deficiencies, and strengthening submissions.
  6. 6Module 2 & 3 Documentation Support — Preparation and review of CTD summaries, overviews, and quality documentation.
  7. 7Biosimilars CTD Support — Specialized CTD support for biosimilars projects, comparative evidence, and regulatory strategy.

Why Choose Byet El Khebra?

  • 20+ Years of Regulatory Expertise
  • 500+ Successfully Registered Products
  • ISO 9001:2015 Certified Quality System
  • CTD & eCTD Expertise
  • Extedo Software Experience
  • Biosimilars Regulatory Expertise
  • Global Submission Support
  • Regulatory Science Framework™
  • Submission Readiness Focus
  • End-to-End Regulatory Support

Global Regulatory Submission Support

Our CTD and eCTD services support submissions for Egypt, GCC countries (Saudi Arabia, UAE, Qatar, Kuwait, Bahrain, Oman), Jordan, the wider MENA region, Africa, Europe, and international markets — aligning documentation with diverse regulatory expectations.

CTD & eCTD Submission Services

CTD Dossier Preparation

CTD authoring and eCTD publishing services to support compliant, high-quality submissions.

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eCTD Publishing & Submission

Professional eCTD publishing, lifecycle management, baseline preparation, sequence validation and submission support for compliant electronic regulatory submissions.

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Frequently Asked Questions

The Common Technical Document (CTD) is the internationally recognized format used for regulatory submissions covering quality, non-clinical, and clinical information.
Yes. We provide CTD preparation, review, gap analysis, remediation, and submission readiness support.
eCTD readiness refers to preparing documentation, structure, and submission components to support successful electronic submissions.
Yes. We provide eCTD publishing, validation, lifecycle management, and electronic submission support.
Yes. We provide specialized support for biosimilars CTD preparation, comparative evidence documentation, and regulatory submission activities.

Ready to Strengthen Your Submission Strategy?

Partner with Byet El Khebra for professional CTD dossier preparation, eCTD publishing, Extedo support, submission readiness, validation, and global regulatory submission excellence.

Request a Consultation