Find Compliance, Regulatory & Consulting Services for Drug Development

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.

REGULATORY SUBMISSIONS FOR CLINICAL TRIALS

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Pharma Service: Clinical Trials

Sub Category: Regulatory Affairs

Regulatory Submissions for Clinical Trials

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Quotient Sciences

Molecule to Cure. Fast.

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United Kingdom

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Quotient Sciences offers modeling & simulations for formulations and clinical designs. Its experts use GastroPlus™ to model biopharmaceutical & PK data, providing valuable insights into the in-vivo performance of molecules & formulations.

CLINICAL TRIAL DESIGN

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Pharma Service: Clinical Trials

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Sub Category: Clinical Trial Design

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DZS Clinical Services

DZS Clinical Services provides expert consultation and advice on the strategic direction of your clinical trial for your drug product or device across many therapeutic areas in the biopharmaceutical, medical device and government and nonprofit sectors.

U.S.A

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CLINICAL DEVELOPMENT STRATEGY

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Pharma Service: Clinical Trials

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Sub Category: Clinical Trial Design

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PPD

U.S.A

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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.

GLOBAL REGULATORY AFFAIRS SERVICES

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Pharma Service: Clinical Trials

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PAREXEL International Corporation

U.S.A

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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.

REGULATORY OUTSOURCING SERVICES

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Pharma Service: Clinical Trials

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Quorum Review, Inc.

U.S.A

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Quorum understands the complexities of device research. Our boards have extensive experience with devices, our regulatory team can help determine the appropriate classifications for your product, and our support staff can guide you through the particulars of reviewing device research.

DEVICE STUDIES

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Sub Category: Medical Devices

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TFS International AB

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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PRODUCT DEVELOPMENT CONSULTING

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Icon Plc

Ireland

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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.

STRATEGIC REGULATORY SERVICES

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KAI Research

U.S.A

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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.

REGULATORY SERVICES

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Lovelace Scientific Resources

U.S.A

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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.

REGULATORY AFFAIRS

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Quorum Review, Inc.

U.S.A

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Quorum has extensive experience with combination products. Our boards and regulatory teams understand the intricacies of combination product research. We can help determine the correct way to manage your study, and we will apply the proper standards for your product.

COMBINATION PRODUCT STUDIES

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Pharma Service: Clinical Trials