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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...
Our client is a global leader in medical devices and pharmaceutical manufacturing industry. Syntel provides complete 3600 product labeling services to the customer for implementing its current GS1 barcode system. The immediate objective was to comply with the Food and Drug Administration (FDA)’s Unique Device Identification (UDI) implementation timelines. Syntel’s...
One of the world’s top 10 global medical devices and pharmaceutical manufacturers was looking for prospective and retrospective validation of Commercial off-the Shelf (COTS) software tools used by their research department. The US Food Drug Administration (USFDA) has stringent guidelines for Computer Systems Validations (CSV). Successful validation demands that a...
Delivering operational efficiency with Document Management systems Client: One of the largest global pharmaceutical companies of the world.
A large Japanese pharmaceutical company wanted to eliminate their dependence on paper-based Trial Master File (TMF) documentation, while standardizing processes and upgrading their technology environment.
The client, a top 10 global pharmaceutical company engaged Syntel to provide end-to-end Trial Master File (TMF) services. Later, as the document inventory increased, they began to face issues such as decentralized processes and a high level of inefficient manual work. They asked Syntel to explore how the TMF process could be automated through the SyntBots intelligent...
The client is a multinational specialty pharmaceutical company headquartered in Canada. They have experienced rapid and exponential growth due to mergers and acquisitions, and asked Syntel to ensure 100% document retrieval capabilities in order to comply with all regulations and audits from health authorities.
The client a German pharmaceutical company, and one of the largest API manufacturers in the world. They acquired a firm that largely operated on paper-based documentation, and asked Syntel to set-up a document management process to support the processing, archiving and retrieval of documents from the acquired company.