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Product Questionnaire

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  • 01: Contact Information

  • 02: Product Information

  • Drop files here or
    • API or BDS Storage Condition
    • Route of Administration
    • 03: Manufacturing Information

    • Component information

    • Conditional Break

    • Stopper / Plunger coating
    • ExcipientGrade (USP, EP, NF, etc.)VendorPart NumberClient or LSNE Supplied 
    • For each type of batch selected show the following questions:

    • Engineering

    • Placebo

    • Clinical

    • Registration / Exhibit

    • Process Validation

    • Non-conditional Fields

      Resets field visibility.
    • Additional Information
    • Incompatible material
    • 04: Safety Information

    • Deactivation Agent
    • 05: Drug Product Testing

    • Conditions Key

    • A = -20°C
      B = 2-8°C
      C = 25°C/60%RH
      D = 30°C/65%RH
      E = 40°C/75%RH

      Please add applicable conditions for each assay using the condition key above.

    • 1M3M6M9M12M18M24M36M48M
    • 1M3M6M9M12M18M24M36M48M
    • 1M3M6M9M12M18M24M36M48M
    • 1M3M6M9M12M18M24M36M48M
    • 1M3M6M9M12M18M24M36M48M
    • 1M3M6M9M12M18M24M36M48M
    • 1M3M6M9M12M18M24M36M48M
    • 1M3M6M9M12M18M24M36M48M
    • 1M3M6M9M12M18M24M36M48M
    • 1M3M6M9M12M18M24M36M48M
    • What additional ICH stability testing is required?
    • 1M3M6M9M12M18M24M36M48M

    • Services Overview
    • Development
      • Formulation Development
      • Lyophilization Cycle Development
      • Generic Product Development
    • Manufacturing
      • Aseptic Fill Finish & Lyophilization
      • Bulk Lyophilization
      • Complex Formulation
      • Non-Aseptic Fill Finish & Lyophilization
    • Analytical
      • Analytical Method Development
      • Analytical Testing
      • ICH Stability
    Services
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    • New Hampshire
    • Wisconsin
    • León, Spain
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