Byet ElKhebra ElDwaea
HomeAbout Us
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

© 2026 MS Web Development. All Rights Reserved.

Privacy PolicyTerms
Product Registration

Product Registration in Egypt

Byet El Khebra provides comprehensive product registration services in Egypt for pharmaceutical companies, biosimilar developers, medical device manufacturers, cosmetics and food supplement companies, and healthcare organizations — guiding each project from regulatory strategy through submission, approval, and lifecycle maintenance.

Request a Consultation
Pharmaceutical Products
Biosimilars
Medical Devices
In Vitro Diagnostics (IVDs)
Cosmetics
Food Supplements

Our Registration Process

  1. 1Regulatory Assessment — Review of product classification, regulatory pathway, and registration requirements.
  2. 2Documentation Review — Assessment of available documentation and identification of regulatory gaps.
  3. 3Submission Preparation — Preparation and organization of registration documentation and supporting materials.
  4. 4Regulatory Submission — Management of submission activities and communication with regulatory authorities.
  5. 5Regulatory Follow-Up — Support for authority inquiries, deficiency responses, and approval requirements.
  6. 6Lifecycle Maintenance — Post-approval support including renewals, variations, updates, and ongoing compliance activities.

Why Choose Byet El Khebra?

  • 20+ Years of Regulatory Experience
  • 500+ Successfully Registered Products
  • ISO 9001:2015 Certified
  • Regulatory Science Framework™
  • Egypt & MENA Regulatory Expertise
  • End-to-End Registration Support
  • Science-Based Regulatory Strategies
  • Proven Regulatory Success

Industries We Support

We support pharmaceutical companies, biosimilar developers, medical device and IVD manufacturers, cosmetics companies, food supplement companies, contract manufacturing organizations, healthcare startups, and healthcare institutions across Egypt and the MENA region.

Our Registration Services

Pharmaceutical Products Registration

Registration strategy and execution across pharmaceuticals, biologics, medical devices, cosmetics, supplements, and disinfectants.

Read more

Biological & Biosimilar Registration

Registration strategy and execution across pharmaceuticals, biologics, medical devices, cosmetics, supplements, and disinfectants.

Read more

Medical Devices & IVD Registration

Registration strategy and execution across pharmaceuticals, biologics, medical devices, cosmetics, supplements, and disinfectants.

Read more

Cosmetics Registration

Registration strategy and execution across pharmaceuticals, biologics, medical devices, cosmetics, supplements, and disinfectants.

Read more

Food Supplements Registration

Registration strategy and execution across pharmaceuticals, biologics, medical devices, cosmetics, supplements, and disinfectants.

Read more

Disinfectants & Antiseptics Registration

Registration strategy and execution across pharmaceuticals, biologics, medical devices, cosmetics, supplements, and disinfectants.

Read more

Frequently Asked Questions

Pharmaceutical products, biosimilars, medical devices, IVDs, cosmetics, food supplements, disinfectants, and healthcare products.
Yes. Byet El Khebra provides specialized biosimilars regulatory support including registration strategy, documentation review, submission support, regulatory consulting, training, and lifecycle management.
Yes. We support medical device and IVD registration projects including classification, documentation review, and regulatory submissions.
Yes. We provide registration support for cosmetics, food supplements, disinfectants, and related healthcare products.
Registration timelines vary depending on product category, documentation readiness, regulatory pathway, and authority review requirements.

Ready to Register Your Product in Egypt?

Whether you are registering a pharmaceutical product, biosimilar, medical device, cosmetic product, food supplement, or disinfectant, our regulatory experts can help identify the most appropriate registration pathway and support your project from planning to approval.

Request a Consultation