Driving success through
strategic business growth
Strategic Regulatory Support
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Development of regulatory strategies from initial engagement with FDA through final FDA approval
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FDA Liaison Services for domestic and International companies
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Assistance with FDA expedited programs for serious conditions
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Post-Approval Compliance: Managing ongoing regulatory obligations, including labeling updates and safety monitoring.
Regulatory Submission Services
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Preparation and submission of regulatory applications, INDs, NDAs, ANDAs, DMFs, and BLAs
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Preparation of FDA meeting requests and briefing packages for Type A, B, C meetings, advisory committees, end-of-phase meetings, and pre-NDA discussions
FDA Compliance Support
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Gap analysis and risk assessment to identify areas of non-compliance
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FDA compliance master plans
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Representation during FDA inspections, audits, and investigations
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Assistance with response to 483 and warning letter remediation
Training Services
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On-site training on FDA requirements for management teams and employees
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Training programs tailored to specific regulatory topics such as GMP compliance or QSR consulting for medical devices
Post-Marketing Surveillance
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Adverse Event Reporting and Medical Device Reporting
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Safety monitoring and post-marketing reporting requirements
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Support for FDA recalls and complaint handling processes
Special Services
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Technical support for law firms specializing in FDA regulations
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Personalized consulting tailored to client-specific needs