Celegence supports customers to streamline end-to-end regulatory information management by optimizing their workflows and configuring systems.
Our consultants understand the importance of data governance, minimizing data duplication, real-time availability of data, and flexible reporting. We help clients use technology to create optimal processes, while managing data in a compliant and efficient way.
We apply our knowledge of regulatory data standards such as XEVMPD and IDMP/SPOR when assessing and implementing solutions.
We help customers to establish a strong and reliable RIMS solution, that can be used as a transparent source of truth across regulatory affairs and beyond.
Managing registration tracking, planning, and reporting for clinical trial and marketing authorization applications is complex due to varying requirements across products and regions. Organizations must track registered product details, approval status, and manufacturing data to ensure accurate reporting and effective signal detection.
Many companies struggle with inconsistent terminology and multiple data sources, making their Regulatory Information Management systems unreliable. This lack of trust leads employees to maintain separate spreadsheets and databases, increasing inefficiencies and verification efforts. Regulators face similar issues, prompting initiatives like XEVMPD and ISO IDMP to standardize data.
Regulatory bodies such as EMA and FDA are driving structured frameworks to improve data consistency. Adopting these standards enables organizations to establish authoritative data sources, ensuring compliance while supporting digital transformation.
Our experts can provide consultation for submissions, liaise with regulatory agencies, lead projects for documentations, and implement QSR.
Manager – Regulatory Data Management
As a manager within Regulatory Data Management at Celegence, John has extensive experience in xEVMPD, IDMP, RIMS, and Regulatory Affairs.
John 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.
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Subject Matter Expert – Regulatory Data Management & Operations
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.
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Senior SME, Regulatory 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.
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Manager, Regulatory Services (Pharma/RIMS)
Pranab Sagar is a regulatory affairs expert with over 16 years of experience, specializing in Regulatory Information Management Systems (RIMS), lifecycle management, and compliance for the pharmaceutical industry. His expertise spans regulatory data management, risk analysis, and strategic planning.
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.
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Data Governance & Regulatory Compliance
Regulatory Affairs Consulting
25 Apr, 2025
25 Apr, 2025
25 Apr, 2025
25 Apr, 2025
From document publishing automation to eCTD submissions and beyond, Celegence is your trusted partner for regulatory affairs excellence. Contact us to learn how we can help you achieve your compliance goals efficiently and cost-effectively.
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