What We Do



Global Focus . . . Integrating Strategies

Our specialties are: 

  •    FDA regulatory strategy 
  •    Submissions
  •    Development and management of 
  •    clinical trials
  •    Quality System compliance, and 
  •    FDA inspections. 

We have a business perspective and know economics drives multinational submissions. We create cost-effective, realistic and timely strategic plans for regulatory approvals and then implement and manage them through all product phases - from conception to completion. We develop a unique regulatory strategy for each product, including a step-by-step pathway to approval. 

We use our knowledge of the unique requirements of national and international agencies to efficiently prepare regulatory strategies, clinical studies and their respective submissions. 

We have the expertise to integrate scientific, medical, regulatory and clinical practice concepts and requirements into a single program for your product.