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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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    01 Quotient Sciences (1)

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    Quotient Sciences

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    REGULATORY SUBMISSIONS FOR CLINICAL TRIALS

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

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    Pharma Service: Clinical Trials

    Category: Compliance, Regulatory & Consulting

    Sub Category: Regulatory Affairs

    Regulatory Submissions for Clinical Trials

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    KAI Research

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    REGULATORY SERVICES

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    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
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    Lovelace Scientific Resources

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      REGULATORY AFFAIRS

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      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

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      Sub Category: Regulatory Affairs
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      PPD

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      GLOBAL REGULATORY AFFAIRS SERVICES

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      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

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      Sub Category: Regulatory Affairs
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      PAREXEL International Corporation

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      REGULATORY OUTSOURCING SERVICES

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      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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      Icon Plc

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        STRATEGIC REGULATORY SERVICES

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        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

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        Sub Category: Regulatory Affairs
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        Litera Microsystems

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          DOCXTOOLS

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          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
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          TFS International AB

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            REGULATORY AFFAIRS STRATEGY

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            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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            TFS International AB

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              INTERACTION WITH REGULATORY AGENCIES WORLD-WIDE

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              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

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              Greenleaf Health Inc

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                REGULATORY POLICY GUIDANCE

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                Greenleaf Health Inc. offers various services such as: Analysis of FDA policies and processes; User fee requirements; Advisory committee analysis; Implementation of new FDA legislation, regulations, guidance documents and FDA standard operating procedures.

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                Pharma Service: Clinical Trials

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                Sub Category: Regulatory Affairs
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                TFS International AB

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                  ORPHAN DRUG DESIGNATIONS

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                  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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                  Greenleaf Health Inc

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