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ProEd has a proven record of providing our clients with first-class regulatory communications services. We hit the ground running with veteran experience in regulatory planning and strategy, competitive labeling, health authority meetings (FDA, EMEA), and REMS (Risk Evaluation and Mitigation Strategy).
When choosing a partner to develop your best message and assist your passage through the perplexities of the regulatory environment, look toward the one agency that has been there before. ProEd has been in scientific and safety communications services since 1991, and we have assisted with the preparations for nearly 100 FDA Advisory Committee and EMEA meetings. Now is the time to contact the trusted name in development and periapproval services—ProEd.
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- Development benchmarking
- Early phase characterization
- Phase II and III planning
- Regulatory strategy
- Strategy
- Presentation development
- Operations
- Speaker training
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- Competitive labeling
- Claims assessment
- Label Development
- Risk Assessment
- Communication plans and Medication Guides
- Elements to assure safe use/implementation
- Monitoring effectiveness
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