REGULATORY SERVICES
DSA will assist you with global regulatory report generation and submission services designed to align with electronic or paper submissions.

Expedited Regulatory Submissions

15-day spontaneous reports
7 and 15-day clinical trial reports

Periodic Reporting

• Periodic ADE Reports (PADER)
• Periodic Safety Update Reports (PSUR)
• PSUR Addendum Reports
• PSUR Summary Bridging Reports
• Assist in harmonizing reporting dates

Additional Report Assistance

• Risk Management Plan Associated Reports
• NDA Annual Reports support
• IND Annual Reports support
• ISS and other contributions

We also provide ad hoc problem solving and research for your regulatory questions. Let DSA make global regulatory reporting easy on you, call us to learn more. DSA understands the changing needs and requirements of the global safety market and will customize the right solution for your company.