Capgemini’s Global Regulatory Practice

Our Global Regulatory Compliance Unit allows us to develop comprehensive regulatory-compliance solutions for the life sciences industry. Because we have privileged insight into the methods of this world-leading governmental agency, we can assess the plight of life sciences’ companies affected by regional and national agencies across the globe. This has proven invaluable to our international clients.

A Team of Experts

The practice is comprised of consultants who have had exposure in a number of areas including:

  • E-submissions
  • Information Systems Architecture
  • Standardized Nomenclature Initiatives
  • Risk Management
  • Adverse Event Management
  • MedDRA
  • Computer Systems Validation.

First-Hand Experience

Besides our involvement with the International Committee on Harmonization (ICH), our consultants have had first-hand experience with European Regulations through their interactions with the European Medicines Evaluation Agency and drug submission efforts, through both Centralized and Mutual Recognition Procedures.