Leadership Team and Subject Matter Experts

With nearly 15 years of industry experience, Sonia envisioned an opportunity to support life sciences companies in bridging the gap between regulatory intelligence and the operational activities associated with compliance.

Prior to co-founding Celegence, Sonia Veluchamy was the Managing Director for ArisGlobal, a company that provides technology solutions for close to 200 life science companies worldwide, including top 10 pharmaceutical companies, with the objective of accelerating drug development and ensuring global compliance for its customers. At ArisGlobal, Sonia led the operations for the company and expanded its customer base to 30 of the top 50 global pharmaceutical companies.

Sonia received her BA in Economics from the University of Chicago and her MBA in Finance & Entrepreneurship from Columbia Business School.

Punya is the Chief Operating Officer of Celegence. Punya is focused on realizing our vision for tech-enabled services, including our AI medical writing platform, CAPTIS®. Punya is highly motivated by the opportunity she sees to improve efficiency for the life sciences industry for developing Regulatory strategies and global expansion. Prior to co-founding Celegence, Punya was a Client Partner for ArisGlobal’s Health Agency customers in Europe.

LGG is the Vice President of Regulatory Services at Celegence. He is part of Celegence leadership team focused on providing high quality solutions and services for Regulatory Affairs. He has 18+ years in software product design, development, project management, implementation and SME consulting for global projects related to life sciences. LGG has successfully managed the global delivery teams for Regulatory services and support for 30+ pharmaceutical, medical devices and biologics companies.

Erin brings over 20 years of experience in medical device and diagnostics, including leadership roles at Medtronic and GE Healthcare.

She has strong expertise in helping clients leverage technology and services to grow their business by solving regulatory, quality and commercial challenges.

Matt is an MBA-qualified Commercial Professional, with over 17 years of experience working in the pharmaceutical and medical device space on technical operations, sales, and business management.

He understands the unique set of challenges clients face when it comes to commercial viability, product status, technical requirements, regulatory position, and growth potential. He strives to generate sales aligned to company growth through the development of strong, long-term relationships with new and existing customers.

Mark has 15 years of sales experience in life sciences, including 8 years in regulatory solutions.

Marloes provides regulatory affairs consultancy and services to both big- and small-sized pharmaceutical companies, covering a wide variety of products.

Marloes holds a master in Life Sciences (Drug Innovation) from the University of Utrecht, the Netherlands. For nine years she held several positions at Hoffmann-la Roche in Switzerland, including the role of regulatory intelligence manager and regulatory policy lead for the EMEA region. Awarded DIA Leader of Tomorrow in 2016. Helped author the biosimilar guidelines across the globe.

Ramesh has significant experience in Medical Device and Invitro Diagnostic Devices, with more than 22 years’ experience in the Life Science Industry – specifically in NPD, PMS, QMS, and Regulatory Affairs.

With 20+ years of Pharmaceutical industry experience across Drug Discovery, Regulatory Affairs, and Compliance, Pradeep is a system and business process owner leading our Pharma division delivery teams. Pradeep holds a Masters degree in Biotechnology from Bangalore University.

• Established a Regulatory Operations team for Consumer Health business unit
• Spearheaded several RIM/eDMS and publishing system migrations
• Successfully managed xEVMPD integration into P&G Healthcare business unit
• Led business process harmonization and digitization activities for raw materials documentation and its compliance
• Co-chaired IDMP office

Dimitar is Director of Engineering with more than 20 years of experience in the software industry. He is a result-focused individual with great track record of success stories in his past.

He has been instrumental in the successful delivery of software solutions for wide-array of industries like automotive, advertising, education, and others. His experience in various positions and stages of the software delivery process combined with his non-compromising attitude toward the quality of the software product helps him provide valuable client solutions

With 14+ years of experience in marketing, Asya has worked in various sectors including creative leadership and consumer brand advertising, and B2B marketing in CRO, CDMO, and clinical technologies / SaaS solutions.

Kristel van Loosdrecht is a senior document and dossier management specialist for Celegence, with over 9 years of industry experience. She has developed comprehensive knowledge in document publishing, quality control of data, and understanding of complex regulatory processes.

Kristel specializes in planning, coordination, and preparation of various electronic submission formats, ensuring they meet the requirements of regulatory authorities across America, Europe, and GCC countries. Throughout her career, Kristel has consistently demonstrated a commitment to timely and accurate delivery of critical documents, ensuring compliance with international standards.

She is known for her attention to detail, ability to collaborate with cross-functional teams, and a track record of successful submissions. With her broad subject matter expertise, she has consistently contributed to the efficient and timely approval of products for a variety of companies.

Mahesh holds a Master’s degree in Pharmacology (MPharma) and brings over 13 years of extensive experience in the regulatory operations domain, with expertise in navigating complex regulatory frameworks and ensuring compliance across global markets.

In the role of Associate Manager, Mahesh combines a meticulous attention to detail with strategic foresight to manage regulatory documentation, streamline submission processes, and uphold quality standards. Mahesh excels in overseeing cross-functional teams, implementing innovative tools to streamline processes, and maintaining the highest quality standards.

Dhana Kumar has 18 years of experience in Publishing and Submission. His expertise includes publishing submission for US, EU and other countries. He acts as a Subject matter expert for Document publishing and Regulatory Submission.

He is trained in publishing software, such as Docubridge and eCTD Manager and has good experience in Adobe and TRS Toolbox and working on Automation for eQC.

Diede is a Regulatory Affairs Subject Matter Expert. She specializes in clinical trial applications and scientific advice, with a primary focus on regulatory processes within Europe, including European Medicines Agency (EMA) and Clinical Trials Information System (CTIS). With experience in Regulatory Intelligence, eCTD template development, and Module 1 documentation support - including electronic Application Forms (eAF), Product Information, and Risk Management Plan (RMP) updates - Diede brings a thorough understanding of regulatory strategies to her role. She holds a PhD in Hemato-pathology and both a Bachelor’s and Master’s degree in Biomedical Sciences. Her academic expertise, combined with her industry experience, enables her to navigate regulatory landscapes and provide guidance to clients.

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.

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.

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.

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.

Dr. Ipshita Chattopadhyaya is a regulatory affairs expert with over eight years of experience, specializing in medical devices. She has extensive expertise in clinical evaluation and compliance with EU MDR 2017/745, covering a range of therapeutic areas, including ophthalmology, orthopedics, and hematology.

At Celegence, she leads the development and review of high-quality regulatory documents, ensuring compliance with MEDDEV 2.7/1 Rev. 4 and MDR requirements. She is also experienced in systematic literature reviews, risk management, and post-market surveillance.

Dr. Chattopadhyaya holds a Ph.D. in Pharmaceutical Sciences and has authored scientific publications in leading journals. Her regulatory knowledge and industry experience enable her to provide strategic guidance on medical device compliance and regulatory submissions.

Dr. Alpa Ben is a Subject Matter Expert in Medical Device Services at Celegence, bringing over 12 years of experience in healthcare and regulatory affairs. With a background in Dental Surgery and clinical practice, she has worked across multiple domains, including Pharmacovigilance, Labeling, Risk Management, Complaints Handling, and Medical Writing.

She has extensive experience authoring and reviewing EU MDR-compliant regulatory documentation, including Clinical Evaluation Plans and Reports, Post-Market Surveillance Reports, and Summaries of Safety and Clinical Performance. Her expertise spans a wide range of therapeutic areas, including dentistry, cardiology, gastroenterology, endoscopy, dialysis, and diagnostic and interventional radiology.

At Celegence, Alpa serves as both an SME and a clinical reviewer, specializing in regulatory documentation for medical devices, from simple technologies to complex Medical Device Software. Her deep regulatory knowledge and multidisciplinary experience enable her to support clients in navigating the evolving medical device compliance landscape.

He holds a Master’s degree in Medical Biology from the University of Utrecht and a Doctorate in Medicines from the University of Leiden, Netherlands.

Fastest EU MAA approval for a monoclonal antibody in an ultra-orphan (at the time). Successfully guided a client through the PIP application process in 9 months (average is 18).

Deblina Rababi is an experienced regulatory professional specializing in medical device compliance under EU MDR. She has expertise in authoring and reviewing Clinical Evaluation Reports (CER), Clinical Evaluation Plans (CEP), Literature Search Reports (LSR), Periodic Safety Update Reports (PSUR), Post-Market Surveillance Reports (PMSR), and Post-Market Clinical Follow-up (PMCF) documentation.

As an Associate Manager at Celegence, she ensures the development of high-quality regulatory submissions, supporting medical device manufacturers in achieving compliance. Her detail-oriented approach and regulatory expertise contribute to streamlined documentation and successful audits.

Dr. Neha Keral is an experienced regulatory professional specializing in clinical evaluation, PMS documentation, and medical writing for global regulatory compliance, including EU MDR, US FDA, TGA, MHRA, Health Canada, NMPA, and HSA. She collaborates with cross-functional teams to develop high-quality regulatory submissions across various therapeutic areas.

With a Ph.D. in Life Sciences focused on antimicrobial and anticancer research, Dr. Keral brings a scientific approach to regulatory strategy. At Celegence, she leads documentation processes, ensures compliance, mentors teams, and drives regulatory excellence in medical devices. Passionate about the intersection of science and medical innovation, she is dedicated to advancing regulatory solutions that impact healthcare.

Tamanna Sahraya is a skilled medical writer specializing in regulatory documentation for medical devices, with expertise in FDA and EU MDR compliance. She has experience authoring Clinical Evaluation Reports (CER), Post-Market Surveillance Reports (PMSR), and Risk-Benefit Assessments while ensuring adherence to MEDDEV 2.7/1 Rev. 4 and MDR standards.

With a strong background in regulatory affairs, literature reviews, and safety analysis, she supports product lifecycle management and clinical data reporting. Her analytical approach and commitment to compliance help streamline regulatory submissions and enhance client collaboration.

Roderick Shilshi is a regulatory medical writer specializing in medical device compliance under FDA and EU MDR regulations. He has experience authoring Clinical Evaluation Reports (CER), Post-Market Surveillance Reports (PMSR), and Risk-Benefit Assessments, ensuring alignment with MEDDEV 2.7/1 Rev. 4 and MDR standards.

With expertise in literature reviews, safety reporting, and regulatory submissions, he supports product lifecycle management and clinical data analysis. His detail-oriented approach helps maintain compliance and streamline regulatory documentation.

Srujana Akkiraju is an experienced medical writer with nearly a decade of expertise in regulatory and clinical documentation. She specializes in authoring and reviewing high-quality regulatory submissions, including CCDS, RMPs, PSURs, and labeling content across multiple therapeutic areas.

At Celegence, she leads a team of medical writers, ensuring compliance with global regulatory standards while optimizing processes for efficiency. With a strong background in scientific writing, quality control, and stakeholder collaboration, she plays a key role in delivering clear, precise, and regulatory-compliant documentation.

Prasad Ravichandran is an experienced regulatory affairs professional with expertise in medical and in-vitro diagnostic devices. An IRCA-certified lead auditor for ISO 13485:2016, he has over 10 years of experience in regulatory compliance, quality management, and clinical trial submissions.

At Celegence, he leads regulatory compliance initiatives, ensuring EU MDR and IVDR adherence while managing technical documentation, risk assessments, and post-market surveillance. His strategic approach and in-depth regulatory knowledge support seamless compliance for medical device manufacturers.

Manicka Sundaram R is a seasoned regulatory and compliance professional with over 14 years of experience, including a decade in the medical device industry. He specializes in design history file remediation, risk management, and compliance with global regulatory standards.