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:
- Information systems architecture
- Standardised nomenclature initiatives
- Risk management
- Adverse event management
- Computer Systems Validation.
Besides our involvement with the International Committee on Harmonisation (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 Centralised and Mutual Recognition Procedures.