Regulatory Affairs
Navigating complex and evolving regulatory landscapes is critical for any business aiming to expand globally. At EOFEX, our Regulatory Affairs Services ensure your products and operations meet the highest international standards while accelerating approvals and minimizing compliance risks.
We provide end-to-end regulatory support, including:
Product Registration
Comprehensive guidance for timely approvals, dossier preparation, and submissions to local and international authorities.
Clinical Trial Applications & Approvals
Assistance in planning, filing, and managing clinical trial documentation and approvals.
Bioequivalence (BE) Study Facilitation
Coordination with certified research centers to design, execute, and manage BE studies that meet regulatory requirements.
GAP Analysis
Identifying regulatory and operational gaps and recommending corrective actions to strengthen compliance frameworks.
ERP Implementation Support
Providing expert guidance for ERP integration to streamline compliance processes and improve operational efficiency.
GMP Compliance, Audits & Upgradation
Support in achieving and maintaining Good Manufacturing Practice standards, conducting internal audits, and implementing facility upgrades.
With EOFEX Regulatory Affairs, you gain a trusted partner who not only ensures compliance but also empowers your business to achieve faster, smoother, and more sustainable market access.