Life Sciences

Saving lives is your core business. Managing the data is ours.

Digital Services

Overview

Syntel enables future-ready life sciences companies to drive faster innovation, process excellence and compliance in an increasingly competitive and highly-regulated industry.

Trial Master File and eTMF Solutions

Document Management

Regulatory Compliance

Product Engineering

Big Data & Analytics

Product Packaging & Labeling

Success Stories

Reducing Label Data Migration Turnaround Time by 35% for a Medical Device Company

The client is a top global medical device company and a worldwide leader in home medical equipment. They were facing issues with data standardization, data duplication and data loss, since past data migrations had been handled manually. They wanted a solution to map data from their existing system to a new one without compromising quality.

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Helping a Client Meet 21CFR11 Regulations and Guidelines

The client is a global medical device, pharmaceutical and biotech company. They were facing increased litigation due to regulatory submissions that did not adhere with FDA 21CFR11 regulations and guidelines. They clearly needed help ensuring that their applications were compliant in GxP regulated areas, so they turned to Syntel based on our life sciences expertise as well as our robust, risk-based computer system validation (CSV) methodology.

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Managed Services Model Helps Save 60% on Label Design, Artwork Management and Proofing

The client is a top global medical device company and a worldwide leader in cardiology and endovascular devices. To keep up with the latest trends, they planned to change their label design and artwork while staying in compliance with regulatory requirements for artwork management. However, they needed to conduct an impact analysis before migrating to the new system.

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Implementing GS1/UDI Compliant Labels for a Medical Device Company

The client is an American manufacturer of surgical instruments. They wanted to adopt GS1/UDI standards, a system used to assign Unique Device Identification (UDI) numbers to medical devices within the healthcare supply chain. UDI compliance is a requirement for any medical device manufacturer hoping to sell their products in the U.S. market.

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Improving Efficiency, Reducing Costs, and Achieving Faster Medical Product Launches

The client is a global medical devices company and a leader in cardiology and endovascular devices. They needed help understanding gaps between current and new FDA guidelines for Class III medical devices, in hopes of improving product quality and reducing the review time. They also wanted to map their existing test methods to the gaps and develop new test methods to close any remaining gaps.

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