Regulatory Affairs

• From US to Europe Services
• Consulting
• Central and Local Outsourcing Operating Model
• Promotional Materials
• Product Marketing Authorization and Life Cycle Management
• Pre Marketing Approval Support
• Interaction with Global Health Authorities
• Health-Care Compliance – France

Regulatory operations

• Readability Testing
• Medical Translations
• RIMS and IDMP
• Data and Document Management
• Regulatory Affairs Artwork and Coordination Services
• Regulatory Publishing

Product development

• End-to-End Regulatory Affairs, CMC, and Quality Solutions
• Clinical Trial Application

Quality & Compliance

• CMC Pre and Postapproval
• Quality Systems Consulting and Operational Quality Assurance
• Regulatory Intelligence
• Audits and Inspection Readiness
• Management of Compliance

Safety & Vigilance

• From US to Europe Services
• EU QPPV and LPPV/LSO
• Pharmacovigilance Consulting
• Case Management
• Medical Writing
• Medical Information
• Literature Watch
• Cosmetovigilance
• Medical Devices and IVD Vigilance

Medical devices

• 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

• 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
• Financial and Legal Ecosystem
• Human Resources