Compliance

Compliance

  • Publishing
  • Project Management
  • Management of timelines and milestones from early development (pre-IND) to post-marketing, including management of IND and NDA/BLA development, preparation and submission and lifecycle management.
  • Developing timelines that include milestones based on our client’s business strategy, development timelines and regulatory pathway in mind.
  • Strategic planning to ensure most expedited and efficient timeline
  • Manage collaborations with external vendors.
  • Nonclinical Monitoring
  • Clinical Monitoring
  • CMC Monitoring