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.

It matters how you get there

How we work matters. How we work is the difference that we bring. It is speed and efficiency, agility and flexibility, quality and experience, responsiveness and value.  But more than this – it’s the passion and dedication to the personalized needs of our clients that our team and every individual working within our team shares.

Therapy area expertise

Oncology | Hypertension | Central Nervous System Disorders | Diabetes | Infectious Diseases | Immuno-oncology | Respiratory Diseases | Quick to apply knowledge to new therapy areas

Clinical development support

Annually, we average >40 clinical study reports, clinical study protocols and amendments, and investigator’s brochures. We support a range of other clinical regulatory documents such as pediatric plans and orphan drug designations.

Submission support

Annually, we average 3 to 5 regulatory submissions. We deliver global regulatory responses, eg, FDA, EMA, Health Canada, Swiss Medic, and Emerging Markets.

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

EXPERTISE

We’re skilled across the full spectrum of clinical regulatory writing.

EXPERIENCE

More than half of the writing team have long-standing expertise (>10 years), which is shared across the whole team.

COLLABORATION

We effortlessly integrate into client teams.

TRUST

Clients have relied on us for more than 25 years, with over 90% repeat business.

LEADERSHIP TEAM

CAROLINE HINKS

HELENA PIGEON

CAROLINE HARRIS

SAM JAWAID

SUE COLLINS

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.

Join our respected and supportive team at Complete Regulatory

Learn more about development opportunities at IPG Health Medical Communications

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