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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

KAI Research

Litera Microsystems

Lovelace Scientific Resources

MPI Research Inc

Mapi Group

Nutrasource

Nuvisan GmbH

PAREXEL International Corporation

Pharmaceutical Product Development, LLC

Prorelix Research

Quotient Sciences

TFS International AB

TransPerfect

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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

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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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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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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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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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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

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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

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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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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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

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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

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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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

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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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

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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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

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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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

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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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

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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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.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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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

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs