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Regulatory Services in Egypt

Regulatory Compliance Experts in Egypt

The Egyptian Drug Authority (EDA) of the Ministry of Health (MOH) is responsible for medicinal product regulation in the country. Many organizations within the EDA work collaboratively to ensure all medicinal products are safely regulated for efficient public access, while maintaining compliance. These organizations include the Central Administration for Pharmaceutical Affairs (CAPA), the Egyptian Pharmacovigilance Center (EPVC), the National Organization for Drug Control and Research (NODCR), and the National Organization for Research and Control of Biologics (NORCB). The current regulatory Services framework is stringent and effective; however, efforts are being made to improve the medicinal product regulation by various measures. These include an increase in transparency in product registration processes, import/export requirements, and efficient access to update databases. Together, these measures could enhance the regulation of medicines and medical products in the country, resulting in patients being able to access safe, efficacious, and high quality products.

As a leading global contender, DDReg’s regulatory services in Egypt provides ongoing support and development of customized strategies during all regulatory phases while keeping track of the most recent regulatory requirements to ensure high quality and timely submissions. We deliver reliable safety measures, ensure risk mitigation, and collaborate with experts to facilitate effortless delivery of product launches, regulatory filings, and market authorizations.

Our Regulatory Consulting Services In Egypt Portfolio Covers

  • Regulatory Strategies and Expert Views
  • Regulatory Due Diligence
  • Gap Analysis and Remediation
  • New Product Authorizations
  • Post Approval Life Cycle Management
  • CMC Advisory
  • API -DMF
  • ICSR Processing and Submission
  • Risk Management
  • Aggregate Reports
  • Signal Management
  • QPPV Services
  • Bio Waiver Justifications
  • Clinical & Non-Clinical Experts Reports
  • IPR Support, including Worldwide Patent Status and Patent Reviews
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Call us on:+1 (302) 601-2755
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