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Overview
Overview of What Pacific-Link Consulting can do for Clients

Overview of our Services

Pacific-Link Consulting offers comprehensive medicinal product development and consulting to clients in the United States, Japan and Europe. An overview of our services include:

  • Strategic development for biologics and drugs with expertise in clinical development
  • Strategic regulatory advice
  • Support for regulatory submissions
  • Pharmaceutical development
  • Business development
  • Product development
  • Auditing and quality management
  • Medical writing
  • Assist with writing grants
  • Clinical trial management
  • Clinical trial applications (CTA’s) in Canada
  • Obtain legal authorized representative in Canada
  • Manage CTA Lifecycle
  • New drug submissions (NDS) in Canada
  • Project management of NDS
  • 510K/Pre-market authorizations (PMA)
  • Project management of 510K/PMA
  • File 510K/PMA
  • Manage 510K/PMA lifecycle
    • Early Phase
    • Late Stage
  • MHLW meeting
  • Japan Orphan Designation
  • Japan Clinical Trial Notification (CTN)
  • Prepare Fast Track Designation Applications
  • Strategize IND Development Programs
  • Project management of IND
  • Strategize NDA/ANDA Development Programs
  • Project management of NDA/ANDA
  • Prepare safety management plans
  • Serve as medical monitor
  • Write serious adverse event (SAE) narratives
  • Prepare, review and file MedWatch forms
  • Perform safety and clinical reconciliations
  • Post marketing Pharmacovigilance
  • Provide guidance of reportability of Individual Case Safety Reports (ICSRs)
  • Review ICSRs from a Regulatory perspective
  • Medical affairs review
  • Quality Assurance

Pacific-Link is committed to support clients to meet their business objectives, project milestones and customizes our approach to the needs of the client company.