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Old Globe

Explore our Services

A trusted regulatory partner who provides flexible and scalable support across the product's lifecycle is a recognized need of many biopharmaceutical companies. We understand your regulatory needs may fluctuate throughout a product's lifecycle as demand for regulatory services may peak during critical phases of drug development. We offer an adaptable approach that provides you what you need, when you need it, without the commitment and expense of full-time hires, ensuring efficient and effective resource allocation. 

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

We partner with you across your product's lifecycle as a standalone service or as part of a cross-functional product team. Our aim is 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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