• New Product Authorisations

    New Product Authorisations

    Presubmission technical data reviews | Gap Analysis | Regulatory Content authoring | Dossier compilation, validation and final submission of new product authorization applications for global filing | Review Gap Analysis & Remediation Advisory | Dossier Authoring - CMC Sections & Summaries | Biowaiver Justifications | SmPC/PIL/PI authoring/Reviews | Agency Query responses

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  • Post Approval Life Cycle Management

    Post Approval Life Cycle Management

    Response to agency queries/notices on marketed products | Variations | Manufacturing Site Transfers | Risk Assessments | Compliance and renewals

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  • Pharmacovigilance Services

    Pharmacovigilance Services

    Drug safety services | Collates, processes and compiles relevant safety information from all sources, including individual cases, published literature and clinical studies

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