When it Comes to Science, We're in our Element.
How we do things will change with the conditions.
Who we are on the other hand, always stays the same.

Capabilities

 

 

At ProEd Communications, we created the industry’s first dedicated regulatory communications team 20 years ago to help our clients secure regulatory approvals and obtain the optimum labels for their pharmaceuticals, medical devices, and biologic products.

Since then our dedicated team of physicians, scientists, and communications professionals has helped more companies succeed in the development and regulatory arena than any other communications firm.

We have helped support more than 110 FDA advisory committee meetings and multiple EU oral hearings with an impressive 80% success rate.

We continue to lead the industry by providing the deepest scientific expertise, the most experienced regulatory strategists and development consultants, and the most effective communicators.

Health Authority Interactions

  • FDA advisory committee preparation
  • EU oral explanation preparation
  • Development milestone meetings (eg, pre-IND, EOPII, presubmission, scientific advice)
  • Health authority responses to questions
  • Briefing document writing and review
  • Advocacy and public relations

Regulatory Consulting

  • Regulatory intelligence
  • Regulatory plans for drug development
  • Filing strategy
  • Target product profile
  • Labeling development and negotiation (professional and patient)
  • Risk management plans and REMS
  • Message development and validation

Clinical Consulting Services

  • Development consulting
  • Submission document development, writing, and review
  • Competitive pipeline assessment
  • Commercial input to development planning
  • Competitive labeling and claims analysis
  • Life cycle strategy workshops

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