Post Approval Reports

Regulatory agencies require companies to submit a number of post-Approval reports. These include IND and NDA periodic and annual reports and EU post approval commitments, extension applications, and notifications of variations and Periodic Safety Update Reports.

PSC can advise you on your reporting obligations. We can assist by collecting and collating data, preparing and revising draft reports, coordinating the review process, and finally submitting the reports with appropriate forms and cover letters to the regulators.

If you would like more information, get in contact with us directly here.