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Our take on the latest developments in scientific communications and regulatory affairs.

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HCG ProEd Regulatory Logo
Inside ProEd
Our take on the latest developments in scientific communications and regulatory affairs.

About ProEd

Inside ProEd
Our take on the latest developments in scientific communications, medical affairs, regulatory affairs and market access.

About ProEd
Since 1991, ProEd Regulatory has helped pharmaceutical, biotechnology and medical device companies communicate complex data in ways that matter – to healthcare providers, the patients they treat, and the regulators who protect them.

We’re MDs, PhDs and PharmDs. We’re RAC-certified regulatory strategists, and communications coaches. We’re graphic designers and programmers. We’re editors and program managers. And we work together with one purpose – to increase knowledge and understanding of therapies that improve patient care.

We work with all types of data, across multiple therapeutic areas, and at all stages of your product’s lifecycle.

We help the world’s leading researchers publish their data in the most prominent medical journals, and help them shine at the podium, while ensuring transparency, objectivity and integrity. We know how to identify and reach the right audience, and craft a story that will resonate with them.

We understand the importance of market access and how to effectively communicate your HEOR data to payors. We bring a quarter-century of relationships to the table, and our disciplined and respectful approach helps you strengthen your relationships with your most important partners.

We create the cool stuff, too – digital tools and experiential programs that bring our clients’ data and patients’ perspectives to life.

We work across all types of companies – from the pharma giants to the biotech start-ups, and across all levels of the companies we serve – from the C-suite to the front-lines. Our programs and processes are built to fit your needs.

We become trusted members of your scientific communications, medical affairs, regulatory, and market access teams, and we work hard to earn your trust – every day.

Scientific Communications

  • Publications Compliance, Planning, and Execution
  • Needs Assessment
  • Scientific Message Platform
  • Interactive Tools

Regulatory Affairs

  • Health Authority Meeting Preparation
  • Global Regulatory Strategy
  • Dynamic Target Product Profile™
  • Submission Documents

Medical Affairs

  • Medical Information
  • KOL Engagement
  • MSL/Internal Training
  • Investigator Initiated Study Support

Market Access

  • Early Product Consulting
  • Building & Communicating Product Value
  • Technical Assessment Meeting
    Readiness
  • Payer Engagement

To learm more, visit www.proedregulatory.com.

Recent Insights

  • New FDA Guidance: Accelerated Approval Accountability
  • New FDA Guidance on the Use of AI to Support Regulatory Decisions
  • Regulating Generative AI: Insights From the FDA’s First DHAC Meeting
  • Regulatory Reforms on the Horizon
  • AI’s Impact on Regulatory Affairs: From Data Management to Decision Making

Archives

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  • August 2021
  • December 2020
  • November 2020
  • July 2018
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  • April 2018
  • March 2018
  • February 2018
  • June 2016
  • May 2016
  • March 2016
  • February 2016
  • January 2016
  • December 2015

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