Regulatory Writing

MABH provides comprehensive Regulatory services across the spectrum of global product development, registration and commercialization. We deliver informed advice and pragmatic services and solutions for new product and market authorizations, Health Authority submissions, post approvals, CMC and lifecycle management to help companies maximize their product’s commercial potential and market success.

MABH Regulatory Writing staff brings together the powerful combination of education, experience and expertise. You can rest assured that we’ll deliver quality reports in an efficient and timely manner, with minimal supervision from you. You can trust our staff to manage the teams, schedules and reporting. We have subject matter experts on the entire spectrum of reports in a product life cycle which include safety and clinical reports and medical communications.

Our individual report writing expertise includes:

  • Quality Overall Summary (QOS)
  • Clinical and Non-Clinical Overviews and Summaries
  • Product Quality Reports
  • Process Development Reports
  • Site Master File (SMF)
  • Aggregate Safety Reports and other Clinical Documents
  • Annual Report