What we offer

Technology-led regulatory innovation across the product development lifecycle, right from regulatory intelligence and planning, to content authoring, submissions, and HA feedback management, ensure compliance in the laborious and dynamic regulatory landscape

Who is it for

Regulatory affairs functions spanning across regulatory intelligence, content creation and submission management functions

Why it’s important

Increase probability and speed of regulatory approvals

Reduce compliance risks with information accuracy and quality

Reduce regulatory costs significantly

How we deliver

What makes us different

Deep regulatory expertise and life-science contextualized technologies

Transformational platforms to drive performance and regulatory efficiencies

Global operating model built on industry best practices to deliver service excellence

100
Timeline and SOP compliance
99.5
Right-First-Time quality score
30
Increase in productivity
Label Lifecycle Management, Regulatory Writing, Regulatory Intelligence and Market Strategy, Packaging Artwork Management, Regulatory Submissions Management, Clinical Trial Disclosures
NEXT Regulatory Intelligence, NEXT Label Lifecycle Automation, NEXT Regulatory Submissions Planning, NEXT HA Query Management