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.
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Clinical study reports (full, abbreviated, synoptic, externally sponsored)
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Investigator’s brochures
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Protocols, amendments, and informed consent forms
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Pediatric investigation plans
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Orphan Drug Designations and Annual Development Reports
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Breakthrough Designations
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IMPDs
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INDs
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Annual reports
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Clinical trials disclosure
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Standard Response Documents
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Regulatory briefing documents for Phase 2/3 study design
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Pivotal clinical study reports
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Patient narratives
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Regulatory briefing documents for submission plans
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Clinical overview
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Clinical summaries (modules 2.7.1 to 2.7.6)
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Risk management plans
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FDA assessment aid
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Responses to regulatory authorities
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Modifications for submissions to regulatory authorities in different regions
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Process optimization
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Lean authoring
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Creation of bespoke training aids
LEADERSHIP TEAM
About Guy Slatcher
A motivational leader and life sciences professional, Guy has a broad background including asset development, clinical research, marketing, medical affairs, medical communications, patient advocacy and publications. He started his career as a Clinical Research Associate in the UK before moving into leadership roles across Global, EU and US markets. He later transitioned into healthcare advertising in New York, where he discovered his passion for medical communications. As Managing Director of Complete Regulatory, Guy is focused on future-proofing teams and shaping the next era of Med Comms. He’s excited to support the incredible Complete Regulatory team and build on the agency’s strong foundation with purpose, energy and a forward-thinking mindset.
ABOUT HELENA PIGEON
Helena is a Senior Editorial Manager at Complete Regulatory. Helena leads management of the training and development of Regulatory Writers, supporting development programmes and providing training, coaching and mentoring, as well as leading programmes of work. Helena started in regulatory writing with Complete Regulatory in 2003. Before joining, Helena gained a PhD in Cell Biology from the University of Manchester and a BSc (Hons) in Biochemistry and Applied Molecular Biology from the University of Manchester Institute of Science and Technology. She has also worked within a clinical studies unit for a small biotechnology company.
ABOUT CAROLINE HARRIS
Caroline is an Editorial Manager at Complete Regulatory. Caroline oversees programmes of work, including leading multiple submissions. She also contributes to management of the group, in particular the training and development of Regulatory Writers. Prior to joining Complete Regulatory in 2000, Caroline was Senior Clinical Submissions Scientist at Pfizer Limited, where she worked for 5 years, before which she spent 2 years at GSK reporting safety data for clinical studies. Caroline holds a BSc (Hons) in Combined Studies in Life Sciences (Human Biological Sciences, Psychology of Human Behaviours and Sociology) from the University of Leicester.
ABOUT SAM JAWAID
Sam is a Strategic Engagement Director at Complete Regulatory. Sam leads business development activities, is actively involved in onboarding new clients and project types, and in coaching and mentoring other members of the team through leadership of projects, including submissions. Sam started in regulatory writing with Complete Regulatory in 2009. Before joining, Sam was a Publications Administrator and Writer at The Institute of Cancer Research, following post-doctoral research, a PhD in Organic Chemistry and a BSc (Hons) in Chemistry with Medicinal Chemistry from the University of Glasgow.
ABOUT SUE COLLINS
Sue is an Editorial Manager at Complete Regulatory. Sue oversees programmes of work, including onboarding work with new clients and in different therapy areas. She also contributes to management of the group, in particular the training and development of Regulatory Writers. Before joining Complete Regulatory in 2011, Sue spent several years working in research, both pure and applied, including with the Ministry of Defence, the Medical Research Council at the Institute of Neurology in London and at the University of Manchester. Sue has a PhD in Neuroscience from University College London and a BSc (Hons) in Applied Biology from Coventry University.
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.