Regulatory Affairs & Pharmacovigilance
Ensuring patient safety and product compliance across every market we serve. “Navigate complex regulations with confidence — backed by our 25+ years of experience.”
What We Offer
At ITROM, we understand the dynamic and ever-evolving pharmaceutical regulatory landscape. Our Regulatory Affairs and Pharmacovigilance services ensure that your products are compliant, market-ready, and aligned with both global and regional regulations.
From registration dossiers to safety monitoring systems, we handle it all — so your focus stays on innovation and patient care.
What’s Included in This Service?
Regulatory Strategy Development
Tailored regulatory roadmaps based on country-specific health authority requirements.
Dossier Compilation & Submission
Preparation and submission of CTD/eCTD files for product registration or variation.
Product Life-Cycle Management
Handling renewals, updates, changes, and variations efficiently.
Pharmacovigilance (PV) System Set-Up
Establishing compliant PV frameworks, SOPs, and safety databases.
Case Processing & Signal Detection
Literature monitoring, ICSR management, and risk-benefit evaluations.
Periodic Safety Update Reports (PSURs / PBRERs)
Timely reporting of post-marketing surveillance data.
Why It Matters
In today’s regulatory climate, non-compliance can mean costly delays, reputation damage, or withdrawal from the market. With ITROM, you gain a partner that ensures:
- Seamless market entry
- Full regulatory compliance
- Active pharmacovigilance aligned with WHO, EMA, and regional guidelines
- Reduced risks and better safety outcomes
Our Regional Expertise
- Familiar with UAE (MOHAP, DHA), Saudi Arabia (SFDA), Egypt (EDA), and more
- Strong liaison with regulatory bodies for faster responses
- End-to-end Arabic and English dossier support
- Experience across human medicines, medical devices, nutraceuticals, and biologics
