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    Regulatory affairs teams are tasked with supporting both expansion and product maintenance. To expand their offerings and move into new markets, they need to keep up with their existing active registrations. RegulatoryOne Local Impact Assessment automates the reuse of existing registrations and simplify the registration process review.

    The Challenge

    The-Challenge-1

    Automatically find matching registrations when registering new products

    Understanding and acting on the registration implications of product changes is a complex, manual process for regulatory professionals. Each relevant registration must be identified, assessed according to its local specific impact rules and then acted upon accordingly. Thus, it is commonly found that seemingly minor product changes tend to quickly balloon into nearly intractable registration change management initiatives.

    The Solution

     

    RegulatoryOne Local Impact Assessment streamlines internal registration review for regulatory teams, enabling user-friendly automation that saves countless hours of manual searching through active registrations. The built-in automation assists users in identifying underlying implications for registrations and dossiers updates quickly. When assessing whether a registration can be reused or an amendment is needed, regional or local differences are automatically identified, allowing users to proceed without delay.

    Product Brief

    The Local Impact Assessment feature of RegulatoryOne allows companies to more effectively manage inherent product evolution and respond to customer needs.

    • Velocity to market - reduce time-to-market by quickly identifying impacted registrations of a proposed product change.
    • Faster Innovation Cycles – reuse existing registrations and already approved content.
    • End-to-End Registration Management - initiate registration events that define the necessary product and market requirements to create or to amend.
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    Customer Success

    BASF Video Quote
     

    "Global collaboration is crucial for us. It is essential to have one source of regulatory information instead of distributed, siloed systems. High availability, reliability, and performance are key. With Veeva Vault, we have a good system in place that supports our needs."

    Armin Sauer, Team Lead Global Regulatory IT Services at BASF

     

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