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An Integrated Business Model Delivers Value

A lack of insight into the evolving regulatory landscape leads to operational inefficiencies; inabilities to drive true value from data; and the absence of end-to-end accountability for real impact on better products, innovation and patient centricity. Through our integrated business model, we support R&D strategy for increasingly specialized product portfolios. 

New Market Conditions Demand New Approaches

Our approach ensures that our customers are regulatory inspection-ready 365 days of the year – with no surprises, dead investments in regulatory gaps or other similar challenges – in a proactive manner. And by building regulatory engagement into companies’ innovation models, we deliver external compliance solutions as a single industry partner. For more insight into the depth of our regulatory services, visit

Accelerating Your Speed To Market 



Extensive Portfolio of Regulatory Consulting Services

  • Regulatory strategy (pharma/biologics/tissue/medical device/combination products)
  • Regulatory submission authoring (IND, CTA, NDA, BLA, MAA, etc.)
  • Regulatory submission remediation
  • Orphan, Fast-Track, Breakthrough and RMAT designation strategy and submissions
  • Collaboration with military branches
  • FDA meetings, Advisory Committee meetings & EMA meetings
  • Regulatory operations – compliant electronic regulatory submissions
  • REMS strategy
  • Medical writing
  • Notified body meetings
  • Post-approval product support
  • Recalls and corrective actions
  • Labeling compliance
  • Advertising and promotion

Call us to learn how we transform data into actionable knowledge that informs decisions and reduces risk.