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Arcinova
Azidus Laboratories
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
Nuvisan GmbH
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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Transforming Drug Development with Science & Innovation.
- 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 & ConsultingSub 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 & ConsultingSub Category: Regulatory Affairs
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- Service Details
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 & ConsultingSub Category: Regulatory Affairs
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- Service Details
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 & ConsultingSub Category: Regulatory Affairs
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- Service Details
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 & ConsultingSub Category: Regulatory Affairs
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- Service Details
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.
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Medical Devices
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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
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Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Consulting 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 & ConsultingSub Category: Regulatory Affairs
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- Service Details
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 & ConsultingSub Category: Clinical Trial Design
Transforming Drug Development with Science & Innovation.
- 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 & ConsultingSub Category: Clinical Trial Design
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- Service Details
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 & ConsultingSub Category: Clinical Trial Design
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- Service Details
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 & ConsultingSub Category: Consulting Services
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- Service Details
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.
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Medical Devices
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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.
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Regulatory Affairs
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- Service Details
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
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Consulting Services
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- Service Details
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 & ConsultingSub Category: Consulting Services
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- Service Details
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.
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Quality & Compliance
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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 & ConsultingSub Category: Clinical Trial Design
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- Service Details
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.
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Quality & Compliance
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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).
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Quality & Compliance
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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
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Consulting Services
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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 & ConsultingSub Category: Regulatory Affairs
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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.
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Overview
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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 & ConsultingSub Category: Consulting Services
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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.
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Training
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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.
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Consulting Services
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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.
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Consulting Services
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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 & ConsultingSub Category: Quality & Compliance
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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.
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Regulatory Affairs
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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.
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Quality & Compliance
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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 & ConsultingSub Category: Regulatory Affairs
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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
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Consulting Services
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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 & ConsultingSub Category: Medical Devices
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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.
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Medical Devices
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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.
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Medical Devices
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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.
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Quality & Compliance
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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 & ConsultingSub Category: Consulting Services
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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 & ConsultingSub Category: Regulatory Affairs
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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™
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Clinical Trial 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.
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Clinical Trial Design
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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
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Veterinary / Animal Health
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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 & ConsultingSub Category: Consulting Services
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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 & ConsultingSub 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 & ConsultingSub Category: Regulatory Affairs
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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 & ConsultingSub Category: Consulting Services
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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 & ConsultingSub Category: Regulatory Affairs
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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 & ConsultingSub Category: Quality & Compliance
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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 & ConsultingSub Category: Regulatory Affairs
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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 & ConsultingSub Category: Training
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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 & ConsultingSub Category: Quality & Compliance
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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 & ConsultingSub Category: Biopharmaceuticals
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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 & ConsultingSub Category: Consulting Services
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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 & ConsultingSub Category: Quality & Compliance
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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 & ConsultingSub Category: Quality & Compliance
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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 & ConsultingSub Category: Quality & Compliance
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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 & ConsultingSub Category: Regulatory Affairs
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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 & ConsultingSub Category: Quality & Compliance
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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 & ConsultingSub Category: Regulatory Affairs
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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 & ConsultingSub Category: Regulatory Affairs
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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 & ConsultingSub Category: Consulting Services
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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 & ConsultingSub 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 & ConsultingSub Category: Regulatory Affairs
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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 & ConsultingSub Category: Training
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- Service Details
eCTD preparation and review, global CTA submissions, Packaging and labeling translation
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Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Regulatory Affairs
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