Core Service
Regulatory Compliance
How is Regulatory Compliance Operationalized for Global Access and Clinical Trials?
Regulatory compliance is operationalized by embedding regulatory strategy directly into program design and execution. This means translating country specific requirements into clear, standardized processes that support consistent oversight, efficient execution, and inspection readiness across regions.
We ensure regulatory compliance through continuous monitoring of the evolving global regulatory landscape, supported by practical, hands‑on experience and direct engagement with regulatory authorities.
Tanner manages regulatory pathways, health authority interactions, and ongoing compliance activities to support global access programs and clinical trial services worldwide.
Our Regulatory Capabilities
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Guide partners through complex regulatory environments to enable compliant medicine distribution on a global basis.
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Lead the preparation of regulatory applications, submission dossiers, and supporting documentation required for regulatory filings and approvals for access programs.
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Coordinate preparation and submission of regulatory documentation in accordance with country-specific requirements and timelines.
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Maintain an in-house database and working knowledge of regulations governing licensed and unlicensed medicine distribution, packaging and labeling, pharmacovigilance, data privacy, and real-world data collection requirements for access programs.
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Provide guidance on regulatory pathways, key timelines, submission requirements, and country-specific obligations.
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Offer strategic recommendations aligned with trial or program goals.
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Manage interactions with regulatory authorities for access programs when delegated by the sponsor.