Regulatory & Safety
MCT handles regulatory submissions and approvals across the Middle East, Africa, Pakistan, and EAEU countries, helping reduce complexity and accelerate Time to Market.
- Rat/Mouse PINP EIA
- IDS-iSYS PTH (1-34)
- Corticosterone EIA
- Corticosterone HS
- Urine CartiLaps EIA
- Rat/Mouse PINP EIA
- IDS-iSYS PTH (1-34)
- Corticosterone EIA
- Corticosterone HS
- Urine CartiLaps EIA
To ensure compliance with local applicable regulations and requirements, we have a Digital Regulatory Database allowing instant access to regulatory insights.
We prepare accurate, country-specific regulatory dossiers in line with local requirements and SOPs. We work closely with local authorities, proactively managing queries to shorten review timelines and avoid delays.
With experts on the ground, we support Sponsors in meeting local safety reporting requirements, managing authority requests, and maintaining oversight throughout the project lifecycle.
We utilize our local expertise to review investigational product labels and ensure they comply with local laws regarding language, content, and layout.