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.

At Celegence, Punya is focused on realizing our vision for increasing efficiency through technology.

Punya’s key responsibility is overseeing the development of our MDR/IVDR compliance platform, CAPTIS^®, as well as our Dossplorer™/Dosscriber™ solutions which unlock efficiencies in management of data and documents for the pharmaceutical industry.

LGG is part of the Celegence leadership team. 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.

Cheryl is a commercial executive with extensive experience in building and scaling high-performing revenue organizations across the pharmaceutical and medical device sectors. She brings a strong track record in driving sustainable growth, leading P&L operations, and supporting strategic transformation initiatives within private equity–backed and high-growth SaaS environments.

Her expertise includes commercial operations, SaaS, and data platform–driven business models, and go-to-market strategy execution. Cheryl is recognized for developing disciplined, metrics-driven revenue strategies and building effective sales organizations from the ground up.

With her experience in revenue leadership and team development, Cheryl contributes to strengthening commercial strategy and supporting scalable growth across life sciences markets.

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.

With 30+ years in pharma, Stef has led global Regulatory Affairs at Astellas and served as Head of RA-EMEA at Merck (MSD), advancing development, approvals, and compliance across international markets.

Extensive experience in strengthening regulatory operations, accelerating product development pathways, and building high-performing teams.

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.

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.

Danielle brings over 26 years of experience in Regulatory Affairs and Operations, Clinical Compliance, and Label Management across the Pharmaceutical and Medical Device industries, with expertise in strategic relationship management.

Her experience includes providing Regulatory Information Management, Trial Master File and SPL, Product Monograph, FHIR & UDI solutions to the Life Sciences industry.

Danielle holds a B.A. from The George Washington University. With her industry experience, Danielle contributes strong account management expertise and aligns unmet industry needs with company growth goals.

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.

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.

Dr. Ipshita Chattopadhyaya is a results‑driven Regulatory Affairs and Clinical Safety professional with over 8 years of experience supporting global clients in CE marking, EU MDR compliance, and lifecycle management of medical devices, combination products, and pharmaceuticals.

She provides strategic SME guidance across diverse international markets, enabling timely certification and sustained regulatory compliance. Her expertise spans Class I–III medical devices, including insulin delivery systems, defibrillators, surgical instruments, catheters and cannulas, respiratory care devices, orthopedic implants, combination and ophthalmic products. She is highly experienced in EUMDR‑aligned clinical evaluation, systematic literature reviews, risk management, post‑market surveillance, and high‑quality regulatory documentation, with additional strength in PSUR and ICSR reporting for FDA‑regulated drugs, ensuring adherence to stringent global timelines and quality standards.

In Celegence, she mentors multidisciplinary teams to deliver complex regulatory projects efficiently. Known for her strong client engagement skills, she consistently balances strategic oversight with hands‑on execution, fostering a culture of collaboration, accountability, and continuous learning. Ph.D.‑qualified in Pharmaceutical Sciences, with publications in peer‑reviewed journals, Dr. Chattopadhyaya is a trusted advisor to clients on regulatory strategy, compliance risk mitigation, and successful market access.

Dr. Alpa Ben is a Senior Subject Matter Expert in Medical Devices Team at Celegence. She brings over 13 years of experience in regulatory affairs and medical writing, with expertise in evaluating EU-MDR compliant documentation.

Her experience includes reviewing CEP, CER, SSCP, PMS, and PMCF and provide scientific justification for equivalence, state-of-the-art, benefit-risk analysis, and clinical claims, supporting compliance with EU MDR. She has worked across various therapeutic areas, including dentistry, cardiology, gastroenterology, nephrology, and diagnostic & interventional radiology.

Dr. Alpa Ben holds a Bachelor of Dental Surgery (BDS) from Rajiv Gandhi University of Health Sciences (RGUHS) and Post Graduate Diploma in Clinical Research and Pharmacovigilance. With her academic and industry experience, Dr. Alpa Ben supports global regulatory programs and contributes to compliant and efficient regulatory outcomes.

Dr. Neha Keral brings over six years of experience in regulatory affairs and medical writing. She specializes in evaluating documentation compliant with EU-MDR, TGA Australia, SFDA Saudi Arabia, and HSA Singapore regulations.

Her expertise includes authoring and reviewing CEPs, CERs, SSCPs, PMS plans/reports, PMCF plans/reports, SOPs, templates, and work instructions. She provides scientific justifications for equivalence, state-of-the-art assessments, benefit-risk analyses, clinical claims, and responses to Notified Body observations, ensuring compliance with regulatory requirements across multiple regions, including the EU, Australia, Saudi Arabia, and Singapore.

Dr. Keral has worked extensively across diverse therapeutic areas, such as dentistry, gastroenterology, neurology, wound care, ophthalmology, otolaryngology, pulmonology, and diagnostic and interventional radiology. She also has extensive knowledge and experience working with SaMD devices. Her proficiency includes understanding ISO 13485, ISO 14971, and ISO 10993 requirements for documentation.

As a Life Sciences Doctorate, Dr. Neha Keral leverages her academic and industry expertise to support global regulatory programs and drive compliant, efficient regulatory outcomes.

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.

Based in the Netherlands, Maurice has over 27 years’ experience in the pharmaceutical and biotech industry, mainly supporting pre-approval drugs and biologics for oncology, pulmonary and cardiovascular indications, with extensive experience in developing regulatory strategies, leading cross-functional teams in health authority interactions (Scientific Advice, both on national and EU level) regulatory intelligence and applications including document development to support applications such as MAAs, CTAs, EU & US Orphan Drug Applications, PIPs, iPSPs, IND Annual Reports and DSURs.​

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.

Maikel Bouman is our Director of Regulatory Operations and Publishing, with 8 years of industry experience.

He has broad subject matter expertise on the quality control of data, document publishing, planning/coordination, management, preparation/creation, and dispatch of different types of electronic submission formats to various regulatory authorities across the Americas, Europe and Australia.

Dr. Pratibha has a Master’s degree in Oral Medicine and Maxillofacial Radiology and has previously worked in academia and healthcare.

Specializes in clinical evaluation of simple-to-complex medical devices, including combination products, and medical device software. She is a BSI-certified expert on regulatory strategy for Clinical Evaluation, Risk Management, PMS including PMCF, and Clinical Evidence pathways for medical devices.

Has authored and reviewed templates and regulatory documentation for medical devices covering a wide range of therapeutic areas – dentistry including implantology, ophthalmology, diagnostic imaging, interventional radiology, general and electrosurgery, nephrology and dialysis, gastroenterology, thoraco-pulmonology, cardiovascular, female reproductive health, wound care, esthetic surgery, instrument reprocessing systems, and specimen management.

Her team of highly qualified medical writers and SME at Celegence has successfully completed several projects on addressing Notified Body observations (BSI, DEKRA, Intertek, SGS, Eurofins, TUVSUD) on the road to CE Marking of medical devices under EU MDR. Her team also handles clinical and regulatory consulting, documentation, and intelligence for other countries/regions such as USA, UK, Canada, Australia, South-East Asia, Saudi Arabia, China and other countries/regions across the globe.

Joseph has 20 years experience in medical device life cycle management and quality management systems (certified to ISO 13485, ISO 9001 & ISO/IEC17025).

Key experience includes preparation and maintenance of technical files, product safety and vigilance reporting, clinical evaluations, risk assessment, regulatory audits, CE and notified body opinion submissions.

Joseph has worked on diabetes management devices, nicotine replacement therapy (NRT) devices and pressurised metered dose inhalers (pMDI); Joseph has worked for small, medium and large Biotech companies such as Roche, OBG Pharmaceuticals and Kind Consumer Ltd.

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.

Kosta is an experienced IT professional based in the Netherlands, with over 12 years of specialized expertise in managing and implementing IT solutions for the pharmaceutical industry, including business-critical applications, such as RIMS, Submission and Publishing, and DMS.

As Product Owner at Celegence, Kosta oversees the continuous development and validation of innovative proprietary software applications. He is committed to delivering high-value solutions through agile methodologies, ensuring that business requirements are effectively translated into technical solutions.

He holds a Master’s degree in Business/Managerial economics from the University of Zagreb.

Dr. Anushree Singh has a Doctorate degree in Neuro-oncology and a Master’s degree in Bioscience (Human Genetics). She has 13 years’ experience in the Life Sciences Industry including 5 years’ experience in Regulatory Writing for Medical Devices. She has authored and reviewed EU MDR compliant regulatory documents for medical devices covering a wide range of therapeutic areas.

At Celegence, she provides strategic advice to customers on regulatory strategy for clinical evaluation, Post-Market Surveillance (PMS) and Clinical Evidence pathways.

She leads a team of qualified medical writers, expert in clinical evaluation of simple-to-complex medical devices, authoring various regulatory documents.

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 and remediating regulatory data, reviewing and updating underlying processes, and fostering a culture of collaboration and innovation among teams to drive successful change.

Shruti Sharma has a deep background in regulatory medical writing, specializing in EU MDR-compliant clinical evaluations for medical devices.

Drawing on her extensive knowledge of regulatory requirements, she translates industry needs into innovative software solutions that enhance efficiency and compliance in the Life Sciences regulatory space.

Shruti is passionate about making technology accessible and impactful, championing tech-enabled process.

Parvathi Nambiar has a Master’s degree in Microbiology and over seven years’ experience in medical writing for pharmaceutical and medical device regulatory affairs. She has authored and reviewed clinical evaluation documentation, post-market surveillance (PMS) documents, Clinical Investigation Plans (CIP), and Clinical Study Reports (CSR).

A subject matter expert at Celegence, she leads a team of medical writers who work on CEPs, CERs, PMS plans, Post-Market Surveillance reports, Periodic Safety Update reports, Post-Market Clinical Follow-up plans, and reports, for devices from a wide range of therapeutic areas including all specialties of dentistry, radiosurgery, diagnostic imaging, in vitro fertilization (IVF)/assisted reproductive technology (ART) devices, cardiac defibrillator, implants, pulmonary, and female health products.

She has successfully addressed feedback from Notified Bodies like BSI, Intertek, DEKRA, and achieved MDR certification for new devices and MDD certified devices. She has also been a panelist on webinars in association with MTI and Q1 Productions, on topics related to Clinical Evaluation.

Smridula holds a Master’s degree in Pharmacy and brings 13+ years of experience in medical device regulatory writing, pharmacovigilance, and clinical research.

She supports global manufacturers across MDR and IVDR compliance through strategic regulatory and safety expertise.

Smridula provides deep expertise in safety database analysis, signal detection, and complaint handling to support regulatory compliance and patient safety.

Dr. Kasturi Rao holds a Doctor of Philosophy (Ph.D.) degree in Cancer Research and a Masters degree in Molecular Biology and Human Genetics.

She has 13 years of experience in the Life Sciences Industry, including 5 years of experience in Regulatory Writing for Medical Devices. She has authored and reviewed various critical documents such as Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post-Market Surveillance (PMS) documentation, Post-Market Clinical Follow-up (PMCF) reports, and Summary of Safety and Clinical Performance (SSCP) documents for medical devices. These documents adhere to EU Medical Device Regulation (MDR) and MEDDEV 2.7/1 Rev 4 guidelines, ensuring compliance and quality.

At Celegence, she leads a team specializing in creating various regulatory documents for different therapeutic areas which include Dentistry, GI -Surgical devices, Nasal and Voice Prothsesis, Implants, etc to name a few.​ Kasturi and team have also successfully addressed feedback from Notified Bodies like BSI, DEKRA, and achieved MDR certification for new and MDD certified devices. She has also been a panellist on webinars in association with MTI and Q1 Productions, on topics related to Clinical Evaluation.

Rohan Sathe holds an M. Tech in Biomedical Engineering from IIT Bombay and has over 10 years of experience in the medical device and clinical trial industry. He specializes in the preparation and review of Clinical Evaluation Reports (CERs) across multiple therapeutic areas.

His expertise includes EU MDR clinical evaluation, Software as a Medical Device (SaMD), Biostatistics, Post-Market Surveillance (PMS), and Post-Market Clinical Follow-up (PMCF), along with addressing Notified Body observations.

Priya Ray Chaudhuri has over 11 years of experience in the Life Sciences industry with a strong focus on regulatory medical writing and clinical evaluation for medical devices. She has extensive experience in authoring and reviewing EU MDR compliant regulatory documents, including Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), and Post-Market Surveillance (PMS) documentation across a wide range of therapeutic areas.

At Celegence, she leads a team of qualified medical writers and SMEs providing strategic guidance to customers on regulatory strategy for clinical evaluation, clinical evidence generation, and post-market surveillance activities including Post-Market Clinical Follow-up (PMCF). She has successfully managed several projects related to clinical evaluation of simple-to-complex medical devices and addressing observations from Notified Bodies clinical review.