Life Sciences Regulatory Compliance Solutions

Regulatory Compliance

Manage compliance issues with the right digital tools.

Global regulations keep coming. Every year they’re released by the thousands, and staying compliant is costly and complicated.

Cognizant’s Regulatory Compliance solutions keep you on track and under control. Our operating model helps you comply with industry standards. Our digital technology experts help with independent validation services and regulatory application development. Our best practices focus on information security management, FDA guidelines on system validation, and electronic records and signatures.

Learn more about our Life Sciences solutions for your business.

Knowledge process outsourcing

Best practices help manage critical business processes including submissions management, labeling, digital asset management, pharmacovigilance case processing, clinical data management and analytics.

Independent validation services

Ensuring timely and efficient computer systems compliance.

Application development and maintenance

Our services are fully compliant with FDA guidelines and global quality standards while leveraging the latest digital technologies, helping you quickly adapt to changing business conditions.

Specialized consulting

Includes the evaluation of off-the-shelf products for Part 11 compliance, working with the Submission Process Re-engineering framework and evaluating the impact of global regulatory updates.

Office of regulatory affairs

Staffed with regulatory affairs experts, our office ensures regulatory compliance for all engagements and offers thought leadership.

SHOWCASE

Featured work

LIFE SCIENCES

Analytics solution improves regulatory compliance

LIFE SCIENCES

Total quality management for patient care

LIFE SCIENCES

AI keeps sensitive pharma information secure

Latest thinking

AI regulation is coming to life sciences: Three steps to take now

Predictive algorithms and AI can speed regulatory compliance by mining data from clinical trials and caregivers, and surfacing potential issues before safety issues are reported to regulators.

LIFE SCIENCES MANAGEMENT

Leadership

Avi Kulkarni

SVP Life Sciences Strategic Business Unit Head

Gayle Flynn

Senior Director, Life Sciences

Take the first step

Serving customers by looking forward as well as back is a big promise, but the power of today’s new digital capabilities is vast and growing.

Let’s talk about how digital can work for your business.