Find Clinical trial regulatory service for Drugs & Devices

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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Regulatory Submissions for Clinical Trials

AAPS 2022 PharmSci 360

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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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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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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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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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Litera Microsystems

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.

U.S.A

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DOCXTOOLS

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TFS International AB

Sweden

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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

REGULATORY AFFAIRS STRATEGY

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TFS International AB

Sweden

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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

INTERACTION WITH REGULATORY AGENCIES WORLD-WIDE

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Greenleaf Health Inc

U.S.A

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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.

REGULATORY POLICY GUIDANCE

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TFS International AB

Sweden

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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

ORPHAN DRUG DESIGNATIONS

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Greenleaf Health Inc

U.S.A

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Greenleaf provides corporate insight on: FDA inspection, compliance and enforcement processes; FDA organization and structure as they relate to compliance functions and decisions; Impact of compliance-related legislation, regulations and guidance; FDA trends and priorities

REGULATORY GUIDANCE

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Chiltern International Ltd

Chiltern’s Strategic Regulatory team is your end-to-end solution for navigating regulatory processes throughout your product’s life cycle. Our team uses a collaborative approach to generate a personalized strategy that aligns with your business goals and gives you the best chance of regulatory

United Kingdom

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CLINICAL TRIAL AUTHORIZATIONS (CTA)

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Chiltern International Ltd

Chiltern’s Strategic Regulatory team is your end-to-end solution for navigating regulatory processes throughout your product’s life cycle. Our team uses a collaborative approach to generate a personalized strategy that aligns with your business goals and gives you the best chance of regulatory

United Kingdom

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IND / IDE / BLA APPLICATIONS

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MPI Research Inc

MPI Research is known for its on-time delivery in meeting the IND and NDA submission filing goals of its Sponsors. We have substantial experience conducting studies in accordance with domestic and international regulatory agencies, including FDA, EPA, USDA, OECD, ICH, and JMHW.

U.S.A

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REGULATORY RECORD

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Chiltern International Ltd

Chiltern’s Strategic Regulatory team is your end-to-end solution for navigating regulatory processes throughout your product’s life cycle. Our team uses a collaborative approach to generate a personalized strategy that aligns with your business goals and gives you the best chance of regulatory

United Kingdom

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REIMBURSEMENT

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Chiltern International Ltd

Chiltern’s Strategic Regulatory team is your end-to-end solution for navigating regulatory processes throughout your product’s life cycle. Our team uses a collaborative approach to generate a personalized strategy that aligns with your business goals and gives you the best chance of regulatory

United Kingdom

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SAFETY RISK MINIMIZATION PLANS

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Nutrasource

Our regulatory team stays abreast of ever changing regulations in the North American market. Our clients have diverse portfolios often crossing different regulatory categories.

Canada

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REGULATORY APPLICATIONS & PRODUCT APPROVALS

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Chiltern International Ltd

Chiltern’s Strategic Regulatory team is your end-to-end solution for navigating regulatory processes throughout your product’s life cycle. Our team uses a collaborative approach to generate a personalized strategy that aligns with your business goals and gives you the best chance of regulatory

United Kingdom

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SCIENTIFIC ADVICE, PROTOCOL ASSISTANCE

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Chiltern International Ltd