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Product Line Extensions and Post-Approval Support
Following the approval of any product, The Weinberg Group provides expert advice and strategies designed to maintain product viability—and continued profitability. We:
- Design product launch communication plans
- Provide strategic support during the product launch process, representing clients before expert advisory panels and in negotiations with regulatory authorities
- Assist clients to ensure compliance with labeling and marketing regulations, including those related to Direct-to-Consumer (DTC) promotion
- Assist clients with drug safety monitoring, post-marketing advertising and pharmacovigilance activities
- Prepare correspondence to FDA for clients in response to citations such as Warning Letters and Notice of Violation letters
- Design, oversee and implement remediation plans to prevent recurrence of violative conditions revealed by internal audits or FDA inspections
- Prepare petitions to FDA to support scientific positions to protect products
- Design risk management programs for drugs with high potential for abuse, misuse, or known adverse events
- Provide technical and strategic support to post-approval activities intended to maintain surveillance of product safety and performance
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