Regulatory Affairs

• 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
• Regulatory Intelligence & Strategy Building

Regulatory operations

• Readability Testing
• Medical Translations
• RIMS and IDMP
• Electronic Common Technical Document
• Regulatory Affairs Artwork and Coordination Services

Pharma IT Solutions

• Start-Up Cloud Solutions
• IT Quality, Compliance, and Security
• Cloud Services

Quality & Compliance

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

Safety & Vigilance

• EU QPPV and LPPV/LSO
• Pharmacovigilance Consulting
• Case Management
• Regulatory 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

Product development

• Biotech End-to-End Solution
• End-to-End Regulatory Affairs, CMC, and Quality Solutions
• Clinical Trial Application
• Regulatory Medical Writing