Consultant Feedback

"The Consultants particular strength has been in identifying and implementing state-of-the-art practices to keep up with and anticipate changes in the regulatory environment."
Senior Director, Top 10 Biotechnology Company
Project/Program Management

Our Project/Program Management support provides consulting to ensure successful Product Development and Regulatory Project Planning is provided to achieve compliant and timely filings with national and international regulatory Agencies. Our consulting support includes:

  • Development of Product Development Plans
  • Development of Target Product Profiles
  • Development of Clinical Development Plans
  • Program Product Management
  • Product Project Management
  • Functional Group Program Management of Regulatory Deliverables
  • Submission Metrics
  • Organizational Design to Optimize Regulatory Submissions
  • Risk Management