What we offer

Fully managed end-to-end digital labelling solution that ensures efficient label content management, streamlined workflow processes, and predictive compliance monitoring through the entire continuum across therapeutic areas, product lines, and markets

Who is it for

Global regulatory affairs, labeling team and their regional/local affiliates

Why it’s important

Accelerate regulatory approvals

Reduce compliance risks with consistent, accurate information

Reduce regulatory costs significantly

How we deliver

Process

We extensively harness AI/ML, NLP, RPA technologies to positively impact the traditional labeling services and processes along with a dedicated innovation team that includes technology experts, data scientists, analysts, annotators, and subject matter experts. 

Our end-to-end label management services include label strategy, global and local label creation and updates (CDS, CSI, USPI, SPCs, Product Monographs, PILs, medications guide), regulatory surveillance across geos, innovator monitoring for generics, regulatory submissions, and HA query management.
Our proprietary AI-driven tools for content automation, submissions, and HA Query management ensure content creation efficiencies and persistent compliance.

What makes us different

Deep labeling expertise and contextualized technologies

Transformational platforms to drive labeling efficiencies

Global operating model built on industry best practices

99.5
Right-first-time quality score
100
Compliance to regulatory timelines consistently
17
Out of top 25 biopharmas
NEXT Label Lifecycle Automation