Medical devices

• Consulting
• Medical Translations
• Regulatory Intelligence
• Medical Devices and IVD Regulatory Affairs
• Medical Devices and IVD Risk Management
• Medical Devices and IVD Quality Assurance
• Medical Devices and IVD Biocompatibility Assessment
• Medical Devices and IVD Vigilance

Biotech-2-Market

• Biotech End-to-end solution
• Strategy consulting service
• Pharmaceutical development, CMC, and quality
• Clinical trials
• Market Access
• Regulatory affairs support
• Marketing and commercial
• Manufacturing and distribution
• Governance and business planning
• Vigilance and medical writing
• Financial and legal ecosystem
• Human resources

Regulatory Affairs

• Consulting
• End-to-End Regulatory Affairs, CMC, and Quality Solutions
• Central and Local Outsourcing Operating Model
• Readability Testing
• Medical Translations
• Promotional Materials
• Product Marketing Authorization and Life Cycle Management
• Pre Marketing approval support
• Clinical Trial Application
• Interaction with Global Health Authorities
• Health-Care Compliance – France
• Regulatory Intelligence
• Medical writing

Regulatory operations

• Consulting
• Central and Local Outsourcing Operating Model
• Readability Testing
• Medical Translations
• RIMS and IDMP
• Data and Document Management
• Regulatory Affairs Artwork and Coordination Services
• Regulatory Publishing

Vigilances & Medical information

• Consulting
• Central and Local Outsourcing Operating Model
• Medical Translations
• Regulatory Intelligence
• EU QPPV and LPPV/LSO
• Vigilance consulting
• Case Management
• Medical writing
• Medical information
• Literature watch
• Cosmetovigilance
• Medical Devices and IVD Vigilance

Quality & Compliance

• Consulting
• End-to-End Regulatory Affairs, CMC, and Quality Solutions
• Central and Local Outsourcing Operating Model
• Medical Translations
• Regulatory Intelligence
• CMC Pre- and Postapproval
• Quality Systems Consulting and Operational Quality Assurance
• Audits and Inspection Readiness
• Management of Compliance