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 our clients with their business objectives and project milestones while offering flexible and customized strategic plans.