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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Pharmacovigilance

Pharmacovigilance Services

Byet El Khebra provides professional pharmacovigilance services that help pharmaceutical companies, biosimilar developers, medical device manufacturers, and marketing authorization holders establish effective safety systems, maintain regulatory compliance, and support post-marketing surveillance across Egypt, the GCC, MENA, and international markets.

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Pharmacovigilance Systems
Safety Reporting
Risk Management Plans (RMP)
Signal Detection & Management
Inspection Readiness
Medical Device Vigilance

Our Pharmacovigilance Services

  1. 1Pharmacovigilance System Establishment — Development and implementation of PV systems supporting compliance and patient safety.
  2. 2Pharmacovigilance Consulting — Strategic consulting for PV operations, compliance programs, and regulatory requirements.
  3. 3Safety Reporting — Collection, evaluation, documentation, and reporting of safety information per applicable regulations.
  4. 4Risk Management Plans (RMP) — Preparation, review, and implementation of risk management and minimization activities.
  5. 5Signal Detection & Management — Identification, evaluation, and management of safety signals for proactive risk assessment.
  6. 6Inspection Readiness — Preparation for pharmacovigilance inspections and regulatory audits.
  7. 7Pharmacovigilance Training — Professional training on PV systems, drug safety, risk management, and compliance obligations.
  8. 8Medical Devices Vigilance — Vigilance systems, adverse event reporting, post-market surveillance, and CAPA for devices and IVDs.

Why Choose Byet El Khebra?

  • 20+ Years of Regulatory Expertise
  • 500+ Registered Products
  • ISO 9001:2015 Certified
  • Pharmacovigilance & Drug Safety Expertise
  • Medical Devices Vigilance Support
  • Regulatory Science Framework™
  • Global Regulatory Experience
  • Compliance-Focused Approach
  • End-to-End Pharmacovigilance Support

Global Pharmacovigilance Expertise

Byet El Khebra supports organizations across Egypt, Saudi Arabia, the UAE, Qatar, Kuwait, Bahrain, Oman, Jordan, Iraq, the wider MENA region, Africa, and international markets seeking effective pharmacovigilance systems, regulatory compliance, and sustainable patient safety programs.

Pharmacovigilance & Vigilance Services

Pharmacovigilance Services

Pharmacovigilance and materiovigilance systems and operations to ensure ongoing compliance and patient safety.

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Medical Device Vigilance (Materiovigilance)

Pharmacovigilance and materiovigilance systems and operations to ensure ongoing compliance and patient safety.

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Frequently Asked Questions

Pharmacovigilance is the science and activities related to detecting, assessing, understanding, and preventing adverse effects or other medicine-related problems.
Yes. We provide pharmacovigilance consulting, compliance support, safety system development, and risk management services.
Yes. We support preparation, review, implementation, and maintenance of Risk Management Plans (RMPs).
Yes. We provide professional pharmacovigilance training programs for healthcare organizations and regulatory professionals.
Yes. We provide vigilance support for medical devices and IVD products including post-market surveillance and adverse event reporting.

Protect Patient Safety and Strengthen Compliance

Partner with Byet El Khebra to build effective pharmacovigilance systems, improve compliance performance, strengthen vigilance programs, and support sustainable patient safety.

Request a Consultation