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    Clinical regulatory services are an important support for all phases of Clinical Trials. With interdisciplinary teams and extensive internal resources companies are flexible and responsible for the smooth running of Clinical Research. The team of regulatory investigators responds to any demand and crisis to avoid issues with non compliances associated with a clinical study. Some major regulatory affairs services are Clinical trial authorizations (CTA), Competent authority meetings, Due diligenc

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    Arcinova

    Azidus Laboratories

    Chiltern International Ltd

    Cliantha Research

    Dalmia

    Greenleaf Health Inc

    ICBio Clinical Research Pvt Ltd

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    KAI Research

    Litera Microsystems

    Lovelace Scientific Resources

    MPI Research Inc

    Nutrasource

    Nuvisan GmbH

    PAREXEL International Corporation

    PPD

    Prorelix Research

    Quotient Sciences

    TFS International AB

    TransPerfect

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    Quotient Sciences

    • FDA
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    UNITED KINGDOM United Kingdom

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    High-Quality Regulatory Submissions

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    - Service Details

    Quotient Sciences’ team possesses an in-depth understanding of the evolving clinical trial regulatory environment in Europe & the U.S., ensuring the production of high-quality dossiers, submission & approval process for Phase I clinical trial application.

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    Pharma Service: Clinical Trials

    Category: Compliance, Regulatory & Consulting

    Sub Category: Regulatory Affairs

    PAREXEL International Corporation

    • FDA

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    UNITED STATES United States

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    Drug Delivery West (DDW)

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    Regulatory Outsourcing Services

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    - Service Details

    Our Regulatory Outsourcing Services include both pre-approval and post-approval activities ranging from the compilation, publishing, and dispatching of large regulatory dossiers to the authoring of routine product variations, annual reports and other product lifecycle maintenance tasks.

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    Pharma Service: Clinical Trials

    Category: Compliance, Regulatory & Consulting

    Sub Category: Regulatory Affairs

    KAI Research

    • FDA

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    UNITED STATES United States

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    Drug Delivery West (DDW)

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    Regulatory Services

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    - Service Details

    We support clinical sites by confirming regulatory compliance and assisting them in preparing, editing, formatting, submitting, and tracking regulatory documents such as informed consent/assent forms, HIPAA notifications, and participant information sheets.

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    Pharma Service: Clinical Trials

    Category: Compliance, Regulatory & Consulting

    Sub Category: Regulatory Affairs

    PPD

    • FDA

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    UNITED STATES United States

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    Drug Delivery West (DDW)

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    Global Regulatory Affairs Services

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    - Service Details

    PPD provides effective global regulatory affairs services for all stages of pharmaceutical, biologic and medical device product development and lifecycle management.

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    Pharma Service: Clinical Trials

    Category: Compliance, Regulatory & Consulting

    Sub Category: Regulatory Affairs

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      IRELAND Ireland

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      Drug Delivery West (DDW)

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      Strategic Regulatory Services

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      - Service Details

      Our regulatory consulting team serves clients around the globe from biotech startups to big pharma as well as the research, investment, and legal firms that serve them.

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      Pharma Service: Clinical Trials

      Category: Compliance, Regulatory & Consulting

      Sub Category: Regulatory Affairs

      Lovelace Scientific Resources

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        UNITED STATES United States

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        Drug Delivery West (DDW)

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        Regulatory Affairs

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        - Service Details

        We always ensure we are in line with the latest regulations and compliance guidelines. We thoroughly assess participant safety and ensure that the participants are committed and motivated to complete their study.

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        Pharma Service: Clinical Trials

        Category: Compliance, Regulatory & Consulting

        Sub Category: Regulatory Affairs

        Litera Microsystems

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          UNITED STATES United States

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          DocXtools

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          - Service Details

          DocXtool for Life Sciences is a Microsoft Word toolbar that accelerates the creation, review, and formatting of your electronic common technical document (eCTD), helping get your documents submission-ready faster.

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          Pharma Service: Clinical Trials

          Category: Compliance, Regulatory & Consulting

          Sub Category: Regulatory Affairs

          TFS International AB

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            SWEDEN Sweden

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            Drug Delivery West (DDW)

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            Regulatory Affairs Strategy

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            - Service Details

            The TFS Global Clinical Development Team provides strategic advice on clinical development. TFS’ team of specialists in clinical development, early phase development, regulatory affairs, and medical experts in a broad range of therapeutic indications support our customers in their clinical

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            Pharma Service: Clinical Trials

            Category: Compliance, Regulatory & Consulting

            Sub Category: Regulatory Affairs

            Greenleaf Health Inc

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              UNITED STATES United States

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              Drug Delivery West (DDW)

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              Regulatory Policy Guidance

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              - Service Details

              Greenleaf Health Inc. offers various services such as: Analysis of FDA policies and processes; User fee requirements; Advisory committee analysis; Implementation of