Regulatory Affairs

Regulatory Writing

Scientific expertise and rigor deliver superior quality

The complexity of regulatory writing is at an all time high, and the intensity and skill level required for the same is constantly expanding. With the ever changing regulatory landscape, organizations are choosing to invest more resources to discrete non-core competence activities.

By partnering with an organization that understands the regulatory guidelines and has the regulatory and analytical background to process your information in a cost effective manner, you can be assured of the best support for your regulatory writing needs and optimal utilization of in-house resources so they can focus on bringing new products to the market and other core activities.

Sciformix’s 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