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CLINICAL SUPPLIES MANAGEMENT HOLDINGS, INC.

Celerion

Chiltern International Ltd

Covigilant LLC

DZS Clinical Services

Dalmia

Elligo Health Research

Evidera

Factory CRO

Greenleaf Health Inc

ICBio Clinical Research Pvt Ltd

KAI Research

LabConnect

Litera Microsystems

Lovelace Scientific Resources

MPI Research Inc

Mapi Group

Navitas Inc

Nutrasource

PAREXEL International Corporation

Pharmaceutical Product Development, LLC

Quorum Review, Inc.

Quotient Sciences

RegPak BioPharma

Reliance Clinical Testing Services, Inc

TFS International AB

TransPerfect

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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

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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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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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Device Studies

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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.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Medical Devices

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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

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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

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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

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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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

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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Clinical Development Strategy

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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.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Clinical Trial Design

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Product Development Consulting

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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: Consulting Services

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Modeling & Simulation

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- Service Details

We provide modeling & simulation for all our formulation design & selection programs. Our experts use GastroPlus™ to model physicochemical, biopharmaceutical & PK data, providing valuable insight into the in vivo performance of molecules & formulations.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Clinical Trial Design

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Goes Direct Approach

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Our team Goes Direct with an approach that redefines the clinical trial process — finding and identifying patients for studies, then providing their physicians with the personnel, processes, technology and infrastructure to conduct them in their own clinics.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Clinical Trial Design

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Pragmatic / Adaptive Studies

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Pragmatic studies aim to quantify the risks, benefits and costs of an intervention in routine clinical practice, often helping to inform how a treatment may be applied by clinicians outside of the clinical trial environment.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

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Combination Product Studies

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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.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Medical Devices

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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

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Quality Assurance

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When contracting with LSR Trials, you can be assured that we will meet all deadlines and the data will be immaculate to ensure a successful trial.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Quality & Compliance

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Supporting All Phases of Drug Development

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MPI Research is a full early-stage drug development CRO that partners with biopharmaceutical, biotechnology, medical device, animal health, and chemical industries to advance global healthcare. MPI Research supports all phases of the drug development pathway, ranging from target identification

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

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Drug Safety Solutions Consultation

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Covigilant’s experts provide strategic advice and risk management services in a broad range of areas for your safety-systems-related operations.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

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Protocol Design

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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

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Clinical Trial Design

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CE Marking

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We are well acquainted with CE-marking studies and can assure that your study can be designed and controlled to meet the demands of Notified Bodies.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Quality & Compliance

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Quality & Regulatory Support

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- Service Details

Mapi provides customers with assistance on quality and compliance matters, including pharmaceutical quality assurance, medical device quality systems, and clinical compliance (GCP).

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Quality & Compliance

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Advisory Services

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- Service Details

Greenleaf’s advisory services include research and analysis of the following potential sources of risk: Marketing authorization; Manufacturing and quality; Promotion; Distribution and supply chain; Pipeline analysis; Compliance status; Labeling; Product safety

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

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Market Access

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- Service Details

Our expert teams of industry leaders, former payers, policy experts, and experienced strategists can help you navigate complex evidence requirements and anticipate and overcome payer barriers to help you achieve optimal price and access.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

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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

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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Protocol Design

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- Service Details

RCTS designs protocols in adherence with International Conference of Harmonization (ICH) and good clinical practice (GCP) guidelines, The research protocol describes in detail how the clinical trial will be conducted.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Overview

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Clinical Supplies & Consulting

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- Service Details

No matter how complex your clinical supplies problems are, our experienced consulting team has the expertise and background to ensure a smooth supply process.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

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Modeling & Meta Research

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- Service Details

Evidera’s expert team of scientists, modelers and statisticians has developed hundreds of simulations, statistical models, and literature reviews to support reimbursement, market access, and internal decision making in all major therapeutic indications and across all major markets.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

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Preparation & Submission of CTA/ITA, IND, PMA...

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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

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Quality & Compliance

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Investigator Training & Support

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- Service Details

If investigator training meetings are required, LabConnect will send a PM to your investigator training meetings in the regions you designate. A detailed laboratory manual will be developed based on the protocol and may be translated upon your request.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Training

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Interaction with Regulatory Agencies World-Wi...

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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

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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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 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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International Clinical Trial Rescue

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- Service Details

We are proud to offer our early-detection program designed to help medical device companies correct poorly designed clinical trials, effectively saving the study from ultimately being rejected by FDA or European regulators.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Quality & Compliance

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Medical Device & Diagnostics

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- Service Details

We have an exceptional depth of knowledge in cardiovascular, ophthalmology, oncology, orthopedic, respiratory and women’s health applications of medical devices. Over the last three decades, our medical device study team has successfully managed hundreds of studies for all classes of medical

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Medical Devices

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Analysis & Expert Consultation

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- Service Details

Greenleaf provides regulatory analysis for strengthening: Corporate quality systems; Corporate training programs; Corporate compliance strategies; Inspection readiness; Corporate quality and compliance organization

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

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Due Diligence

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- Service Details

TransPerfect has developed Trial Interactive–the world's only clinical trial solution specifically designed to meet the needs of life sciences. Now, companies that are participating in licensing activities can securely share confidential product development information through an easy-to-use,

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

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Orphan Drug Designations

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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

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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Simplify Study Design

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- Service Details

During study design, it’s critical to to optimize protocol design and global placement to achieve predictable delivery and avoid amendments that slow the process. After all, 55% of trial delays happen at the site level[1], which can have a cascade effect downstream. PAREXEL's ForeSite™

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Clinical Trial Design

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Medical Device Evaluation

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- Service Details

The medical device expertise available at MPI Research offers pharmaceutical and biotechnology companies leading-edge experience, efficiency, and precision.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Medical Devices

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Pharmaceutical & Medical Device Testing

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- Service Details

RCTS offers complete clinical testing services for topical drugs and medical devices. Our team has extensive experience in the design and execution of protocols to support the safety and therapeutic benefits of topical drugs and devices across numerous therapeutic areas.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Medical Devices

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Quality Assurance of Trials

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- Service Details

Our long experience in validating clinical studies has allowed us to strengthen internal procedures to maximize accountability, systematic feedback, and quality control in all aspects of studies and data handling.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Quality & Compliance

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Protocol / Study Design

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- Service Details

Our extensive experience and knowledge can help you plan a optimal study design. In addition to our internal expertise, you can get direct market feedback through meetings with panels of clinical experts. Let us be your bridge to the key opinion leaders and surgical experts throughout Europe.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Clinical Trial Design

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Animal Health

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- Service Details

MPI Research supports the animal health industry through early stage research conducted under Good Laboratory and Good Clinical Practices (GLP, GCP). We’ve earned the trust of industry colleagues through our decades of animal health safety experience and expanded capabilities including, GCP

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Veterinary / Animal Health

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Clinical Trial Authorizations (CTA)

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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

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eFeasibility

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- Service Details

TransPerfect’s eFeasibility solution allows investigators to populate information into a web survey, then relaying the information to the investigators. These surveys can be done completely online or they can be printed out and done in hard copy, and uploaded via email or fax upon preference.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

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Pediatric Investigational Plans (PIPs)

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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

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

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Regulatory Guidance

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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Regulatory Record

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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FDA Regulatory Strategy

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- Service Details

Factory’s team has a broad and in depth knowledge on FDA requirements and procedures and can help you design a regulatory strategy specific for your device.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Quality & Compliance

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Corporate Training & Development

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- Service Details

Greenleaf provides training and development for: Issuing technical reports, determining policies and procedures, and revising company SoPs; Preparing for FDA meetings and facilitating effective interactions with FDA; etc.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Training

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IND / IDE / BLA Applications

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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

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Biopharmaceutical Development

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- Service Details

Celerion consults in the scientific and regulatory phases of biopharmaceutical product development. Our scientists are very engaged in the practical interpretation of the requirements for biosimilar drugs emerging in Europe.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Biopharmaceuticals

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FDA Communications

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- Service Details

Greenleaf provides evaluation and response recommendations for: Facility and supply chain audit reports; cGMP deficiency letters; Establishment inspection reports (EIRs)nFDA Form 483s; Warning letters; Untitled letters; Other compliance- and enforcement-related actions.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Quality & Compliance

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Timelines & Budgetary Control

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- Service Details

Controlling development timelines and budgets are essential for companies that want to bring a medical device to the market. Factory’s control systems give you all the information you need to keep you informed and stay in control of the process, every step of the way.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

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Product Labeling Testing

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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: Quality & Compliance

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Clinical Quality & Compliance Services

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- Service Details

PPD's clinical quality assurance (CQA) services help our clients ensure the integrity of their clinical trials. We advise clients on how to verify the integrity of scientific data and ensure adherence to protocols and international regulatory guidelines. We also help clients protect research

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Quality & Compliance

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Reimbursement

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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

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European Regulatory Strategy

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- Service Details

We would be happy to provide a free consultation about your European regulatory strategy, without any future obligation. We can assist with Notified Body selection and negotiations.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Quality & Compliance

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Global QA & Compliance

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- Service Details

At TFS we strive to ensure costs are kept within the budget using our in-depth knowledge of international and local regulatory requirements and our network of global investigators to ensure that the trial objectives will be met on time.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Quality & Compliance

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Regulatory Applications & Product Approvals

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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Safety Risk Minimization Plans

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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

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PPD Consulting Services

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- Service Details

With more than 25 years of experience, PPD brings diverse expertise across therapeutic areas and functional disciplines to provide biopharmaceutical consulting services throughout the product life cycle.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

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Scientific Advice, Protocol Assistance

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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

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Learning Management Systems (LMS)

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- Service Details

TransPerfect LMS can help you assist with meeting your global regulatory training requirements.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Training

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Suitability for Registration

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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

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Regulatory Consulting Services

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- Service Details

eCTD preparation and review, global CTA submissions, Packaging and labeling translation

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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Global Regulatory Services

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- Service Details

Leveraging our regulatory experience and familiarity with the tobacco industry, allows us to assist clients as they navigate the evolving regulatory pathway toward product approval.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Tobacco

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Clinical Regulatory Affairs

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- Service Details

Our regulatory team stays abreast of ever changing regulations in the North American market. We take the stress out trying to understand the differences in regulations, classification and requirements between Canada and the United States.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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Medical Device Development Industry Expertise

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Clients can accelerate the process of bringing their new products to market with the experience, resources and global reach of PPD’s medical device development team.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Medical Devices

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Regulatory Consulting

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Over the last three decades, our medical device study team has successfully managed hundreds of studies for all classes of medical products.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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Parexel's Education Services

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PAREXEL's Education Services offers flexible, customizable and end-to-end technology training and training compliance solutions to increase clinical trial and regulatory performance.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Training

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Your Strategic Guide in Product Development

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PAREXEL Consulting overcomes the obstacles to get products to market faster and smarter. Our scientific, regulatory, and operational expertise puts best practice standards to work for clients large and small, designing solutions for a constantly evolving healthcare landscape.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

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Quality Assurance

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TFS Quality Assurance (TFSQA), an independent group within TFS, is responsible for ensuring the quality of the work provided by TFS, and that all work is conducted in compliance with applicable GxP guidelines, relevant regulatory requirements and applicable Standard Operating Procedures (SOPs).

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Quality & Compliance

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Strategic Clinical Consulting

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At Navitas we take a personalized approach to each client situation to ensure results are grounded in industry best-practices, but tailored to specific needs, fit-for-purpose, cost-effective, scalable, and compliant.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

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Regulatory Affairs

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DRDL is providing an effective strategy of Pharmaceutical APIs, Finished Formulation and New medical device registration in India with the help of our network partner in the segment.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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Medical Devices

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Launch your Medical Device in the market with DRDL. We have built the absolute roadmap by keeping in view the FDA, EMA and other necessary regulations. Where, we are keeping a top view on the data monitoring, safety and risk-management.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Medical Devices

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Regulatory Affairs

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ICBio being one of the best CRO in India provides regulatory services to facilitate all stages of drug development. We provide a wide range of Regulatory Writing Services & project management services across clinical & post marketing stages.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

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Regulatory Consulting

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Navitas Life Sciences has the capabilities to support the regulatory end-to-end lifecycle management across the entire value chain of drug and device regulatory environment.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

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Dossier Development (CTD / eCTD)

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We do offer Dossier compilation as per Asean Common Technical Dossier (ACTD), Common Technical Dossier (CTD) Guidelines, Drug Master File. We draft data for BMR, MFR, Process & Analytical Validation, Stability Study reports, COA & related reports.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Overview

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Clinical Consultancy

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RegPak has extensive experience of the preparation, submission and approval process for clinical trial applications in major clinical trial conducting countries.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

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Strategic Regulatory Consulting

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Navitas Life Sciences consultants which bring over 100 years of combined experience, serve as trusted advisors, providing strategic counsel backed by years of experience, industry benchmarks and insights.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

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Medical Governance

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At Navitas, we have worked with companies to ensure medical decisions are consistent throughout the business enabling them to approach external stakeholders with a single voice.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

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