Advise

• Marketing Applications - provide technical advice to insure development process is acceptable to Regulatory Authorities
• Post-Approval Submissions - coordinate post-approval requirements to maintain current status and support proposed changes
• Certificates of Suitability - prepare original and renewal applications
• Product Histories- consolidate historical filings into cumulative registration profiles

Optimize

• Strategy - devise innovative approaches to complex issues
• Presentations - recommend techniques to facilitate acceptance of regulatory proposals and plans
• Risk Management - encourage science and risk-based regulatory approaches
• Health Agency Interactions - assist with management of meetings, inspections, responses

Comply

• Industry Guidances - published by Regulatory Authorities for regional implementation
• Company Governance/Directives - established to define required operating principles applicable to all sites
• Local Procedures - created to provide site-specific details
• Gap Analysis - technical assessment of compliance with approved regulatory filings; mitigation and remediation of gaps