Global Regulatory Compliance

We use our proven, sophisticated tools to identify risks and gaps and implement solutions that achieve compliance and enhance business operations, helping our clients to pioneer Part 11 compliance.

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.

Related Solutions