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Explore Rubicon’s Regulatory Consulting Services 

Rubicon offers scalable regulatory consulting services for life sciences companies, enabling biopharma teams to navigate fluctuating needs throughout the development timeline. Rubicon employs a flexible model ensuring on-demand access to an experienced regulatory professional without the cost of full-time hires. 

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Whether you're preparing for a submission, meeting with regulators, or launching a global product, our biopharma regulatory support services are designed to meet the moment. Rubicon supports and leads Health Authority engagement strategy with global regulatory requirements, streamlines execution, and accelerates your product’s development across the development lifecycle using our full suite of end-to-end regulatory services. 

Health Authority Interactions

  • Global regulatory strategy
  • Global support in the US, Europe, Canada, Latin America, Australia, and Japan
  • Preparation of meeting material & representation at Health Authority meetings
  • FDA Advisory committee meetings

Regulatory Designations

  • Orphan
  • Fast Track
  • Breakthrough
  • Regenerative Medicines Advanced Therapy (RMAT)
  • Priority Medicines (PRIME)
  • Small and Medium sized Enterprise (SME)
  • Emergency Use Authorization
  • Special Protocol Assessments

Regulatory Operations

  • Policies & procedures (SOPs)
  • eCTD templates
  • Regulatory systems support & electronic archiving
  • Budget management
  • Publishing vendor oversight

Competitive Intelligence 

  • Regulatory intelligence & landscape analysis
  • Investor due diligence
  • Market access & feasibility assessments 

Labeling Support

  • Target profile support
  • Target product label development
  • Company Core Data Sheet & regional labeling support
  • Post-approval labeling and PIL support

Pediatric Plans

  • ​Pediatric Study Plans (PSP)
  • Pediatric Investigational Plans (PIP)

Project Management

  • Global submission planning 
  • Regulatory project and lifecycle management for IND/CTA & NDA/BLA

Inspection Readiness

  • Bioresearch monitoring (BIMO) inspection readiness
  • Gap assessment of regulatory policies, procedures, and systems
  • Regulatory support for mock inspections​
  • Remediation support and regulatory communication strategy

Regulatory Support Across the Product Lifecycle

Rubicon partners with you across your product's lifecycle as a standalone service or as part of a cross-functional product team and aims to provide services based on your product's specific lifecycle needs.
Laboratory testing setup

Drug Discovery & Candidate Selection

  • Strategic planning for IND/CTA enabling studies

  • Pipeline review & optimization

  • Development of initial regulatory roadmap

  • INTERACT meeting support

  • Target profile development

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