Regulatory Services

Global pharmaceutical companies are facing an increasingly onerous regulatory regime across different phases of their product life cycle from drug discovery to marketing authorization.

TCS' Regulatory Services help global pharmaceutical companies ensure patient safety and achieve timely and centralized regulatory inputs in conformance with regulatory requirements across jurisdictions.

The TCS Advantage

ValueBPS: Our ValueBPS approach helps enterprises achieve significant and sustained business outcomes by leveraging our deep domain expertise and operations redesign methodologies such as FORE™. Our approach also encompasses robotic process automation (RPA), analytics and insights, our unique IT-BPS synergy, Business Process as a Service (BPaaS) models, and business process management (BPM).

Industry Domain Expertise: We have deep domain knowledge and technical expertise about the life sciences industry. Our services have enabled the publishing of more than 56,000 reports and submissions till date, including over 10,000 direct submissions to regulatory authorities.

BPaaS/Platforms: Our Regulatory Information Management platform provides end-to-end submission management and facilitates correspondence between the Health Authority and pharmaceutical companies.

Solutions We Offer

TCS Regulatory Services provides end to end Regulatory submission management that helps reduce overheads and boost operational efficiency, enabling large pharmaceutical companies to rapidly commercialize their drugs, and thus, attain sustainable competitive advantage.

We offer the following services:

  • Submission planning and co-ordination
  • Technical Authoring
  • Publishing and submissions
  • Regulatory Information Management

Benefits

Our end to end submission management services have enabled our clients to focus on core competencies such as new molecule research and product development, and to bring products to market more quickly.

Key benefits we deliver include:

  • Over 90% improvement in turnaround time (TAT) for regulatory submission
  • Over 95% compliance in regulatory submissions
  • Near 100% accuracy in regulatory service documentation
  • Up to 50% faster scaling up of resources

Reach Us.

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