Driving end to end regulatory excellence for life sciences
The life sciences industry is evolving, and technology advancements demand changes in how Regulatory functions operate. Accenture leads the next evolution by applying leading-edge solutions across the drug, biologics, and device lifecycle that unifies innovative technologies with compliance-focused processes.
Accenture’s gamut of regulatory services includes and is not limited to submission strategy, RIM system implementation and management, dossier and lifecycle management, publishing, IDMP assessments & data collection, tech & data strategy and roadmap, operating model optimization, health authority interaction management and submission authoring utilizing generative AI. Accenture tracks submissions from early drug development through submission, approval, and the end-to-end drug lifecycle.
Accenture helps life science companies capitalize on Intelligent Automation benefits that go beyond the tangible gains of cost, quality and productivity improvements.
Submissions volume in Health Authority submissions annually
What we do
Accenture Life Sciences R&D supports established as well as emerging biopharma players with their end-to-end regulatory services, thereby enabling a sustainable model to meet and cater to regulatory compliance. Accenture is working with our clients to deliver compliance-focused regulatory outcomes to health authorities across the globe.
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
Imagine a global, harmonized database where all information relating to medicinal product can be found. IDMP represents an opportunity to drive cross-functional solutions that bring together people, process, and data, breaking all the traditional silos industry has been struggling with to date.
Through the research conducted by the innovation team at The Dock, and collaboration with our regulatory practice, Accenture has brought together artificial intelligence and the need for regulatory compliance.
Explore how we are innovating with life sciences companies to adopt AI within regulatory functional groups such as Drug Labelling and CMC/Manufacturing to stay compliant. Learn more about innovation in regulatory.
Accenture and TOPRA IDMP Readiness Webinar
AI in Regulatory
INTELLIGENT LIFE SCIENCES [REPORT]
Redefining Regulatory through Intelligent Automation