Regulatory Affairs Service Provider in Egypt
Regulatory Affairs Services in Egypt are managed by the Egyptian Drug Authority (EDA) of the Ministry of Health (MOH), which is responsible for overseeing medicinal product regulation. Various bodies within the EDA regulatory drug approval process in Egypt work collaboratively to ensure that all medicinal products are rigorously controlled and safely accessible to the public, maintaining full compliance. These include:
- Central Administration for Pharmaceutical Affairs (CAPA) – Oversees product registration, pricing, and inspection of manufacturing facilities and pharmacies.
- Egyptian Pharmacovigilance Center (EPVC)
- National Organization for Drug Control and Research (NODCR)
- National Organization for Research and Control of Biologics (NORCB)
This current regulatory affairs framework in Egypt is stringent and effective. However, ongoing enhancements such as improving transparency in product registration processes, streamlining import/export requirements, and upgrading access to regulatory databases are underway. These initiatives align with global benchmarks, such as WHO maturity level 3 attained in November 2024 resulting in safer, more effective access to highquality medicines and medical products
Why choose DDReg’s Regulatory Affairs Services in Egypt?
DDReg offers Regulatory Affairs Services in Egypt with customized regulatory strategies across all product lifecycle phases. We maintain uptodate knowledge of the EDA regulatory drug approval process in Egypt, ensuring high-quality, timely submissions. Our services include:
- Reliable safety measures and risk mitigation through collaboration with global experts
- Seamless support for product launches, regulatory filings, and market authorizations
- Regulatory affairs consulting tailored for new products, lifecycle management, and compliance with Egyptian law
Drawing from DDReg’s global leadership in regulatory affairs, pharmacovigilance consulting firm , and quality services, we enable efficient navigation of the Egyptian market’s regulatory landscape.
Our Regulatory Consulting Services In Egypt Portfolio Covers
- EDA Regulatory Affairs Consulting
- Regulatory Strategies and Expert Views
- Regulatory Due Diligence
- Gap Analysis and Remediation
- New Product Authorizations
- Post Approval Life Cycle Management
- CMC Advisory
- API -DMF
- Regulatory Certification
- eCTD Regulatory Publishing and Submission
- Regulatory Labeling
Our Regulatory Affairs Consulting Services in Egypt portfolio covers:
Regulatory Strategies
The pharmaceutical industry operates under stringent regulations to ensure the safety, efficacy, and quality...
New Product Marketing Authorizations
Navigating marketing authorization is a complex and time-sensitive process. Every country has its own regulatory framework...
Gap Analysis and Remediation
In the highly regulated pharmaceutical industry, maintaining compliance is critical. Regulatory gap analysis helps identify deficiencies in technical documentation...
Regulatory Due Diligence
Regulatory issues arise unexpectedly and can create significant strain on a company’s resources. As such, it is advisable for all companies to carry out regular and frequent regulatory due diligence and audits...
API & DMF services
Drug Master Files (DMFs) contain confidential and detailed information regarding API processes—from manufacturing to storage. DDReg’s DMF Services deliver precise...
CMC Advisory
DDReg’s CMC services are dedicated to assisting customers in developing robust and an efficient regulatory strategy through all development phases - authoring...
Post Approval Life Cycle Management
Maximize product value with expert pharma lifecycle management. Our dedicated team ensures that your product remains on shelves and compliant with ever-evolving regulations through strategic post-approval management...
Certification Services
Partner with DDReg to navigate the complex process of regulatory certification of pharmaceutical...
ANDA and MA Holder Services
Our comprehensive services support both Abbreviated New Drug Applications (ANDA) and Marketing Authorization processes.
Publishing & Submission
Our comprehensive digital solution transforms traditional paper dossier submissions into a streamlined electronic format. With robust infrastructure and cutting‐edge management processes...
