Expert Solutions

Our Regulatory Affairs Services

Byet ElKhebra ElDwaea provides comprehensive regulatory registration, lifecycle, and post-approval services across the healthcare and life sciences sector.

Product Registration

End-to-end registration strategy and execution across medicines, biologics, devices, cosmetics, supplements, and disinfectants.

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Regulatory Submissions (CTD & eCTD)

CTD dossier preparation plus eCTD publishing and compliant submissions.

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Quality & Compliance

QMS implementation, GSDP readiness, compliance audits, and inspection preparation.

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Post-Marketing & Vigilance

Pharmacovigilance and medical device vigilance to ensure compliant post-market safety.

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Training & Regulatory Consulting

Regulatory consulting and hands-on training in regulatory affairs, CTD/eCTD, and quality systems.

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