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Regulatory Communications



FDA Advisory Committee Preparation

Since 1997, ProEd has helped more than 130 teams navigate the FDA Advisory Committee process with an 85% success rate. We help your team understand your audience, define strategies to address committee and agency concerns, craft a clear, concise, and compelling scientific story, and train and test your team to address the challenges of the day with confidence.


Submission Readiness

Our submission-readiness workshops and advisory boards ensure that your critical submission documents set the stage for AdCom success.


Health Authority Meeting Support

We apply our proven process to help you prepare for your critical regulatory meetings–from EU Oral Hearings, to end-of-phase or pre-NDA meetings.


Strategic Regulatory Communication

Our strategic approach to briefing documents, white papers, orphan applications, and other key regulatory communications can help you better anticipate concerns and develop a more effective dialog with regulators.


EXPLORE OUR CASE STUDIES



Over time, we have amassed a wealth of experience that we apply to our services within the regulatory space. We combine this expertise to custom tailor solutions that fulfill your goals and objectives.


 

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PROED REGULATORY TEAM



LEADERSHIP

Greg Connel

EVP, Strategic Communication

Mary Rofael, MD

President

Kim Hayes-Widdersheim

VP, Client Services

Jeff Riegel, PhD

VP, Medical and Scientific Communications

TEAM

Brian Davis

Keith Widdersheim

Kacey Zeiser, MA

Mike Hobert, PhD

Shalini Murthy, PhD

Aaron Csicseri, PharmD

Bill Sinkins, PhD

Chris Barnes, PhD,
ISMPP CMPP™

Ann Marie Fitzmaurice, PhD

Vinay Pasupuleti, MD, MS, PhD

Rezan Sahinkaya, PhD

Hossein Torkabadi, PharmD, PhD

Holly Cappelli, PhD

Sarah Schandle, PhD

Amanda Vreeland, PhD

Kenyatta Nickens

Gayle Meehan, CTC

Sharon DeNunzio

Allen McCrodden, MBA

Jim Cozzarin, ELS, MWC®

Angela Belkin

Sandy Kratochvil

Seth Wawak

Gene Novik

Ray Hunziker

Matt Lewis

Bob Shaddock

Ed Laukiavich

Steven Brunn, MEd

Tamar Harbaugh

Sari Rizk

Kelly Calandro

Julie Deel

Jessica Lauschin

Jennifer Prosek

Staci Good

Connie Comella

Katie Leavy

Dan Pallotta

Our Locations



ProEd Communications, Inc.

25101 Chagrin Blvd. Suite 230
Beachwood, OH 44122

216-595-7919

Healthcare Consultancy Group

488 Madison Avenue, 5th Floor
New York, NY 10022

203-992-6703


OPPORTUNITY

CHALLENGES

SOLUTIONS

RESULTS


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