Our 505(b)(2) services integrate regulatory strategy, data science, clinical planning, and commercial foresight—tailored to your product’s unique positioning.
Regulatory and Pathway Strategy
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Assess feasibility of 505(b)(2) vs. 505(b)(1) or 505(j) routes
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Select and justify reference listed drugs (RLDs)
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Evaluate the need for new data vs. bridging
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Map exclusivity and patent barriers, including potential carve-outs
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Prepare for and lead FDA meetings (e.g., Pre-IND, Pre-NDA, Type C)
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Bridging and Data Package Design
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Perform literature searches and assess suitability of published data
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Design nonclinical/clinical bridging studies (BA/BE, PK/PD, safety)
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Develop scientific rationale for partial reliance on existing data
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Compile bioanalytical and statistical justification for FDA reliance
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Align bridging strategy with labeling, safety, and risk profile goals
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Submission Preparation and Lifecycle Management
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Author or QC submission components (eCTD modules, meeting packages, etc.)
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Support FDA interactions post-submission (clarifications, IRs, DRs)
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Strategize around potential post-approval commitments
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Plan lifecycle extensions via additional indications, routes, or formulation
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Phase 4: Clearance and Supply Chain Recovery
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Confirm removal from import alert or release of detained shipments
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Help restart shipments with clean documentation and validated controls
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Implement ongoing compliance monitoring systems at the facility level
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Conduct post-release audits or mock inspections to ensure sustained compliance
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Build future readiness to reduce re-alert risk
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