Healthcare Services
Communication Strategy
ECG Message Matrix℠
FDA Communication
• AdComm Meeting Prep
• End of Phase 2 Services
• NDA / BLA Messaging
• Post-Approval Negotiation
• Q & A Preparation
• Special Circumstances
Investigator Meetings
MEDCAC Preparation
Presentation Coaching
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Post-Approval Services
ECG is skilled in helping sponsors negotiate post-approval commitments with forceful scientific advocacy and well-reasoned argument.
Addressing safety accurately and strategically, we prepare the team to form initiatives and to structure responses that meet company and regulatory requirements. With ECG, the team builds comprehensive and consistent messages and claims for post-approval documents, presentations, teleconferences, agreements, and meetings.
ECG assists teams in building their strongest case regarding:
- Negotiation of labeling changes
- Post-approval assessment meetings
- Post-marketing monitoring
- Evaluation of the aggregate public health benefit
- Post-market review and data requirements
- Post-market drug safety programs and systems
- Evolving risk profiles
- Balancing of risk/benefit
- All REMS processes
- FDA Drug Watch web page, Patient Information Sheets, and Healthcare Professional Information Sheets
ECG's scientific and rhetorical expertise matters in Post-Approval Commitments.
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