Data Governance & Regulatory Compliance Services

Sowmya is a Regulatory Affairs professional with over 15 years’ experience in training teams (onsite and offshore) and gathering requirements. She excels in providing SME support, managing data optimization, and overseeing variation management projects for xEVMPD submissions.

With a strong background in project management, Sowmya strategically contributes to various roles and ensures successful project execution. As a validation lead in Computer System Validation (CSV), she ensures compliance in both pre- and post-approval regulatory data management.

Her expertise includes IDMP assessments, gap analysis, and data mapping, driving efficiency and regulatory adherence throughout the product lifecycle.

With an engineering background and four years of experience in life sciences, Koen brings sharp analytical and critical thinking skills to both internal and client projects. He specializes in regulatory submission planning, Regulatory Information Management Systems (RIMS), and the implementation of new tools and processes into existing operations. His expertise spans project planning and management, reference and master data management, computerized system validation, and system implementation—ensuring seamless compliance and operational efficiency.

At Celegence, he leads regulatory initiatives, ensuring high-quality data integrity, process optimization, and seamless collaboration with stakeholders. With a strong background in clinical research and vendor management, he plays a key role in driving compliance and operational efficiency in regulatory services.

Yusuf Azzeddine Leenen is a regulatory operations professional specializing in eCTD publishing, xEVMPD submissions, and regulatory data management. With expertise in EMA regulatory systems, IDMP readiness, and dossier submissions, he ensures seamless compliance with global health authorities. At Celegence, he supports regulatory data analysis, document publishing, and system administration while also providing external training on EMA regulatory processes. His technical proficiency and analytical approach contribute to efficient regulatory operations and data integrity.

He has supported numerous pharmaceutical companies in their digital transformations by selecting the right regulatory information management system, extracting & remediating regulatory data, reviewing and updating underlying processes, and fostering a culture of collaboration and innovation among teams to drive successful change.

Vamsi has over 10 years of experience in regulatory operations, working across areas like Regulatory Publishing, IDMP Data Readiness, Regulatory Information Management, xEVMPD Submissions, User Acceptance Testing, and Project Management. He brings a solid understanding of the regulatory landscape and helps clients navigate complex processes with ease.

Currently, he supports clients with Regulatory Data Management, IDMP Data Collection, Data Migration, and Gap Analysis. He also assists with Data Governance, Business Process Improvement, Metadata Management, and Document Management Systems, helping to make regulatory processes more efficient and effective.