WHO WE ARE

 

Through the development of critical documentation, we ensure the timely and successful progression of drugs through every stage of the clinical development process.

We are a team of highly specialized experts. We bring genuine passion and a personalized approach to the distinct needs of every client, changing lives in the process.


Complete Regulatory is part of IPG Health, connecting over 45 agencies and 6000+ people across six continents. Driven by a healthy obsession with harnessing creativity, technology, and science, IPG Health inspires healthcare solutions and behaviors that fuel better health.

WHAT WE DO?

Complete Regulatory is a specialized group of experienced regulatory writers, within IPG Health Medical Communications, that provide high-quality medical writing and project management services.

We support rapid progression of drugs through every stage of the clinical development process.

  • Clinical study reports (full, abbreviated, synoptic, externally sponsored)

  • Investigator’s brochures 

  • Protocols, amendments, and informed consent forms

  • Pediatric investigation plans

  • Orphan Drug Designations and Annual Development Reports

  • Breakthrough Designations

  • IMPDs 

  • INDs 

  • Annual reports 

  • Clinical trials disclosure 

  • Standard Response Documents

  • Regulatory briefing documents for Phase 2/3 study design​​​​​​​

  • Pivotal clinical study reports

  • Patient narratives

  • Regulatory briefing documents for submission plans

  • Clinical overview

  • Clinical summaries (modules 2.7.1 to 2.7.6)

  • Risk management plans

  • FDA assessment aid

  • Responses to regulatory authorities

  • Modifications for submissions to regulatory authorities in different regions

  • Process optimization

  • Lean authoring

  • Creation of bespoke training aids

LEADERSHIP TEAM

CAREERS AT COMPLETE REGULATORY

Our people are the heart of our business, and we take our responsibility seriously when it comes to ensuring they have endless opportunities to grow in their career, leading their own way, at their own pace. 

That’s why we offer a variety of progressive talent development programs and a proactive career management approach that allow you to thrive wherever you are in your career – from our industry-leading entry-level program, Fuel, to Northstar, our brand new groundbreaking development initiative for experienced medical communications professionals.

CONNECT WITH US