Regulatory Services (Pre market) Learn More

Regulatory Services Learn More

Regulatory Reporting & Consulting  

  • Regulatory strategy
  • Regulatory writing and documentation
  • Opportunity assessment

 

For more information about regulatory reporting and consulting, please contact us

FDA Guidance

  • Document preparation
  • Meeting preparation
  • Scientific expertise
  • Data management and analysis
  • Risk management and mitigation

 

For more information about FDA guidance, please contact us

Periodic Regulatory Reporting

  • Regulatory compliance oversight
  • Data management and analysis
  • Report generation
  • Continuous monitoring and adaptation

 

For more information about periodic regulatory reporting, please contact us

Risk Evaluation and Mitigation Strategy (REMS) Development and Fulfillment

  • Risk assessment and strategy development
  • REMS plan design and implementation
  • REMS program monitoring and evaluation

 

For more information about REMS development, please contact us

Product Label Changes

  • Labeling compliance review and monitoring
  • Labeling updates and revisions
  • Labeling implementation

 

For more information about product label changes, please contact us

Abuse Potential Assessment

  • Study design and protocol development
  • Data analysis and interpretation
  • Safety monitoring and adverse event reporting

 

For more information about abuse potential assessment, please contact us

Risk Assessment

  • Risk identification and evaluation
  • Data analysis and interpretation
  • Safety monitoring and adverse event reporting
  • Eight-Factor Analysis

 

For more information about risk assessment, please contact us