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Regulatory Services

Regulatory redefined

Our experience


years of​ Regulatory Services offerings




Health Authority submissions annually

What we do

Regulatory Operations Services

Supporting the entire submission process, from IND submissions to gaining global health authorities’ approval to Lifecycle Management.

Regulatory Affairs Services

Helping clients with Health Authority guidelines to meet Global agency requirements for Regulatory compliance, production, and scientific criteria etc.

Technology and Digital services

Achieving goals through implementing RIM tech, automation engineering including authoring using generative AI, adopting emerging digital technologies​

Consulting and Strategy Services

We help streamline and optimize processes and present cost reduction by reengineering regulatory businesses 

StartingPoint Submission Authoring Suite

Helping companies achieve greater speed and efficiency in authoring, reviewing, and publishing submission documents. Learn more​.

Medical Writing Operations

Providing high-quality and timely medical writing solutions to meet the expectations of sponsors, regulators and the medical community. 

Consumer Goods Regulatory Operations Services

Ensuring Regulatory Compliance across Product Life Cycle from Raw Material & Supplier Management, Label & Artworks to Registration with authorities.​

Innovation in Regulatory: The art of the possible


Redefining Regulatory through Intelligent Automation


Research and Development

We help reimagine R&D for pharma, bio and MedTech companies in a world that values patient outcomes.

Life Sciences

Combining new science with leading-edge technology to helping companies deliver better patient outcomes.

Our leaders

Thomas Philipose

Managing Director – Regulatory Domain, Life Sciences R&D

Shobhit Shrotriya

Managing Director – Life Sciences R&D Operations

Valerie Collins

Senior Manager – Regulatory Operations, Life Sciences R&D

Laura Rohrbaugh

Senior Manager – Regulatory Operations, Life Sciences R&D

Sanjib Ghosh

Senior Manager – Regulatory Operations, Life Sciences R&D

P Srinivasa Rao

Manager – Regulatory Operations, Life Sciences R&D

Janusz Araucz

Manager – Regulatory Operations, Life Sciences R&D

Jeffrey P. Emme

Manager – Strategy & Consulting, Life Sciences R&D