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Molecules Bio

Consulting & Guidance Services

  • Guidance related to Regulatory and Clinical Compliance

  • Guidance related to Regulatory submission compilation

  • Building Regulatory Operation department (from the ground up)

    • Drafting Procedure Documents (SOPs, Work Instructions)

    • Business requirements and business cases assessment

    • Software Selection

    • Gateway setup

  • Support submission deadline (typically lasts 3-4 weeks)

    • Operational guidance

    • System troubleshoot

    • Last-minute changes

    • Agency Gateway issues​

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