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Arcinova
Azidus Laboratories
Chiltern International Ltd
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
Quotient Sciences
TFS International AB
TransPerfect
CANADA
GERMANY
INDIA
SWEDEN
UNITED KINGDOM
UNITED STATES
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.
- Directory Listing
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.
- Directory Listing
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.
- Directory Listing
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.
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Regulatory Affairs
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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.
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: 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.
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Regulatory Affairs
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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
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 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
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
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
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 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
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
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
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
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
eCTD preparation and review, global CTA submissions, Packaging and labeling translation
- 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. We take the stress out trying to understand the differences in regulations, classification and requirements between Canada and the United States.
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Regulatory Affairs
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- Service Details
Over the last three decades, our medical device study team has successfully managed hundreds of studies for all classes of medical products.
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Regulatory Affairs
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- Service Details
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.
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Regulatory Affairs
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- Service Details
Azidus offers preparation of regulatory dossiers for semi-regulated & regulated markets, preparation of dossiers in CTD format for Market Authorization in various countries, review & preparation of all modules of CTD for regulatory submission.
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Regulatory Affairs
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- Service Details
We offer regulatory & consultancy services to support our clients at every stage of their project whether you require help preparing regulatory dossiers or data assessment.
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Regulatory Affairs
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- Service Details
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.
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Regulatory Affairs
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- Service Details
Nuvisan provides a wide range of regulatory services such as Regulatory Support to Clinical Trials (IMPDs, Preparation & submission of CTAs) Regulatory Strategy & Development, Preparation of Application Dossiers in CTD format.
- Directory Listing
Pharma Service: Clinical Trials
Category: Compliance, Regulatory & ConsultingSub Category: Regulatory Affairs
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