Challenge

The life sciences industry routinely faces compliance and reporting issues within the regulatory environment, resulting in a delayed product registration process and thus, staggered access to new medicines and treatments. Traditional systems retain data in silos and are unable to respond to the health authority (HA) queries. In addition, label discrepancies are seldom addressed in time due to absence of an able solution that can identify regulatory requirements & automate label creation.

TCS Solution

TCS ADD™ Regulatory solution leverages AI, mobility and blockchain to automate regulatory processes. The solution can search and analyze large sets of regulatory data from diverse sources to create submission-ready regulatory documents and enable quicker drug registration. The solution comprises the following capabilities:

• Integrated tracking & oversight - Enables tracking of integrated and actionable regulatory processes

• Automated regulatory activities – Facilitates intelligent redaction, data de-identification, review, quality control and formatting of regulatory content

• Regulatory intelligence hub –Enables smart search engine to provide repository of regulatory data, requirements and guidelines that accelerates creation of HA responses and submissions

• Automated regulatory document creation – Integrates and reuses data, documents and templates from multiple sources

Benefits

  1. Increased efficiencies & reduced workload

  2. Up to 50% reduction of submission management activities

  3. Improved data quality and oversight

  4. Increased user engagement

  5. Faster drug registration process