Product Lifecycle Management Services in Mumbai

(2 service providers available)
  • Post Approval Changes Submission Services

    Post Approval Changes Submission Services

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    • Service Location: All India
    • Service Mode: Online/Offline
    • Duration: Depends On Scope of Work

    To enhance productivity and to optimise the operational cost, medicinal product manufacturers propose certain changes to the registered content of the medicinal product applications/dossiers. Any change to the registered content of medicinal products should be submitted to the respective Health Authority (HA) in the appropriate submission procedure with supporting data prior to its implementation. Based on the impact of the change, the requirement of prior approval would be determined referring to the CMC post-approval Regulatory affairs submissions (post-approval supplements/amendments/CMC variations) guidelines of the respective HAs. In this phase, the importance of the Regulatory strategy for post-approval Regulatory affairs changes submission is significant.

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  • Product Lifecycle Management Services

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    Product Lifecycle Management Services, Aerospace Engineering Services

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