Medical Affairs & Regulatory Services

The life sciences industry faces increasing complexity in regulatory compliance, driven by evolving global standards, rising documentation demands, and stringent timelines. These challenges often strain resources and hinder innovation.

At Wipro, we specialize in transforming Medical Affairs & Regulatory operations with tech-infused solutions tailored for life sciences. By leveraging automation, advanced analytics, and domain expertise, we enable organizations to streamline submissions, ensure compliance accuracy, and accelerate time-to-market.

Our regulatory tools & platforms empower clients to navigate regulatory complexities confidently, freeing them to focus on advancing patient outcomes and driving innovation in a highly regulated environment.

What We Do

Medical Affairs Support

Enhancing patient and healthcare provider experiences through intelligent automation, we offer comprehensive management of medical information, safety reporting, and FAQ support.

Dossier Compilation, Publishing & Submission

We organize regulatory submission documentation with authoring & review of CMC documents, CSRs, IBs etc. which are regulatory compliant. Helping with publishing and submission for all the types viz. eCTD, NeeS, paper ensuring a smooth and efficient approval process.

Lifecycle management & Post-Approval Changes

Regulatory compliance throughout product lifecycle, assessing impact of new regulations, managing regulatory documents, renewal & withdrawal of marketing authorization and regulatory reporting on PAS changes, CBE-30, CBE-0, Annual Notification, Type IA, IB, II variations. Regulatory response to health authorities & post-approval management.

Labeling & Artwork Management

Assist with the creation and review of CCDS or CCSI, PILs, and tracking of country-specific labeling standards. On-time implementation of regulatory labeling changes to meet regulatory standards and appeal to consumers and enhance brand visibility.

Regulatory Intelligence

Provide timely and accurate updates on regulatory changes, regulatory market intelligence reports customized to client, trends and best practices for 140+ countries enabling clients to stay compliant.

Regulatory Data Management

Robust data management solutions that include RIM system implementation, management of product information including compliance information, IDMP implementation & data collection, data governance.

Nurturing Success

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