Pharmacovigilance
Ensuring patient safety and regulatory compliance through comprehensive drug safety services
Epidis Pharma delivers end-to-end pharmacovigilance services for pharmaceutical, biotech, and medical device companies operating in Egypt. Our qualified pharmacovigilance professionals manage adverse event reporting, safety databases, and regulatory submissions in full alignment with EDA, ICH, and EU GVP standards.
Our Expertise
Pharmacovigilance services in detail
Key Benefits
Why choose our pharmacovigilance services
QPPV Expertise
Qualified Person for Pharmacovigilance providing local representation and expert drug safety oversight in Egypt.
EDA Compliance
Full alignment with Egyptian Drug Authority pharmacovigilance requirements and reporting obligations.
International Standards
Processes aligned with ICH E2A/E2B/E2C/E2D guidelines and EU Good Vigilance Practice (GVP) modules.
Patient Safety
Robust safety monitoring systems that protect patients and support informed benefit-risk assessments.
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Related services
Supply Chain
GSDP-compliant pharmaceutical warehousing, cold chain logistics, and nationwide distribution across Egypt.
Learn more →Regulatory Affairs
CTD/eCTD dossier preparation, EDA registration, and full regulatory lifecycle support for pharma, devices, veterinary, cosmetics, and supplements.
Learn more →Local Representation
Regulatory sponsorship, LAR services, MAH support, and health authority liaison in Egypt.
Learn more →Protect patients and ensure drug safety compliance
Our pharmacovigilance team provides the expertise you need to meet EDA and international safety requirements.