Cortellis Regulatory Intelligence™
Product Description
Clarivate
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GB -
2015On CPHI since
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5000+Employees
Company types
Primary activities
Categories
Clarivate
-
GB
-
2015On CPHI since
-
5000+Employees
Company types
Primary activities
More Products from Clarivate (12)
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Product Cortellis CMC Intelligence™
Cortellis CMC Intelligence product is a comprehensive database of guidelines / granular collection of CMC data requirements for initial registration of small-molecule and biologics drugs around the world that can be used to avoid delays in product approval and successfully bring a drug to the market (launc... -
Product Cortellis Drug Discovery Intelligence™
Biology, chemistry and pharmacology data -all in one place. Accelerate drug development with early, comprehensive intelligence. Collating the necessary data to identify the likelihood of a drug's success as early as possible requires considerable resources. Cortellis Drug Discovery Intelligence(TM) ... -
Product Cortellis HTA Intelligence™
Increase successful submission outcomes in markets worldwide with comprehensive, expertly analyzed regulatory and market access information 1. Get treatments to patients faster Compare and monitor regulations quickly across markets to understand regional health technology assessment (HTA) outcomes. 2. Main... -
Product Cortellis Product Intelligence™
Cortellis Product Intelligence is a comprehensive source of global drug, market, API, and patent data that helps innovators, CDMOs, generics and API manufacturers grow their business and build robust supply chains. -
Product Cortellis CMC Intelligence™
Cortellis CMC Intelligence™ product is a comprehensive database of guidelines / granular collection of CMC data requirements for initial registration of small-molecule and biologics drugs around the world that can be used to avoid delays in product approval and successfully bring a drug to the market (laun... -
Product Cortellis Competitive Intelligence™
Gaining a competitive edge in drug development requires monitoring the current pipeline while keeping an eye to the future. Cortellis Competitive Intelligence™ delivers timely intelligence to survey the entire development landscape and provides comprehensive analysis to forecast trends, threats and opportu... -
Product Cortellis Drug Discovery Intelligence™
Biology, chemistry and pharmacology data –all in one place. Cortellis Drug Discovery Intelligence™ can help fine chem manufacturers and custom synthesis organizations grow their business by finding and prioritizing new opportunities:
-Access integrated chemistry, organic synthesis and drug pip... -
Product Cortellis Deals Intelligence™
Benefit from the industry's highest quality and largest deals database. Effective deal making is crucial for company growth, getting drugs/devices to market and overall commercial success. Cortellis Deals Intelligence™ provides the essential data foundation to quickly find the most optimal deal without com... -
Product Cortellis HTA Intelligence™
Increase successful submission outcomes in markets worldwide with comprehensive, expertly analyzed regulatory and market access information:
-Get treatments to patients faster Compare and monitor regulations quickly across markets to understand regional health technology assessment (H... -
Product Cortellis Clinical Trials Intelligence™
Confidently and efficiently plan and design clinical trials by reducing time spent compiling and analyzing protocols, sites, outcomes, endpoints and more. Avoid costly protocol amendments, recruitment delays and trial failure by tracking competitive trials, selecting experienced sites, defining the right e... -
Product Cortellis Regulatory Intelligence™
Keep up to date with regulations, maintain biopharma regulatory compliance and make the right strategic decisions.
Navigate the regulatory landscape and efficiently drive strategic decisions
-Comprehensive repository of pharma regulatory intelligence Get full and time... -
Product OFF-X
Monitor and anticipate toxicology and safety signals, mitigate safety liabilities and de-risk assets across all phases of drug R&D and post-marketing.
Make confident development and investment decisions with comprehensive translational safety intelligence. OFF-X™ provides integrated pr...
Clarivate resources (2)
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News API market tested by COVID-19 but pandemic is accelerating adoption of supply chain solutions: CPHI panel
CPHI Discover panel of industry experts discusses impact of COVID-19 on API manufacturing and trading as well as the controversial topic of reshoring production -
Brochure Cortellis Product Intelligence for Generics manufacturers
Actionable intelligence to identify unique product opportunities and reputable, cost-effective sources of API.
Frequently Viewed Together
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Product IT/EU REGULATORY AFFAIRS - Support and management of RA practices
OP Pharma has been providing all-around services in the Regulatory Affairs field for more than 20 years to small to big pharma Companies in Italy as well as in the European Union.
Our expertise ranges from submission of registrations, variations, prices, texts, renewals (also via CESP), to CEP and...
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Product Data Sciences
You need data rapidly to make crucial decisions during a study. Faster data means we can provide our customers with earlier interim data and interim PK reports for on-study dosing and formulation decisions.
We understand on-study changes to early phase study designs and d...
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Product PharmaLex
PharmaLex is one of the largest providers of Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance worldwide. Our global teams of experts can take you through early strategic planning activities and nonclinical requirements to clinical deve...
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Product Analytical Services
With 55+ years of experience, our expert teams develop 1,000+ analytical methods and validate 250+ methods annually. Drawing upon an extensive range of analytical technology, combined with a wealth of analytical knowledge, we can add real value to your drug development and commercialisation programs....
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Product Clinical Research Solutions
We design and execute clinical trials so new therapies get to market in the quickest and safest way possible. Full-Service Solution: We manage and execute full-service clinical trials across major therapeutic areas within medical device, diagnostics, drug, and biologic. Functional Service Provisi...
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Product Formulation Development
Recipharm offer formulation development services for all dosage forms. We develop everything from simple formulations for early studies to more complex formulations suited for commercialisation.
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Product Approvals And Registration
Lomapharm GmbH provides wide range of services which includes approvals and registration. One can benefit from the long experience with a large range of pharmaceuticals and their preparation, including analysis. From analysis to approvals: We are a competent partner for solid, liquid and sterile produc...
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Product Clinical solutions: Trials
Conscio's in-house clinical Unit has been operating since 2007, with more than 600 BA/BE/PK studies completed and proprietary of over 270 validated bioanalytical methods. Equipped with a 60-bed on-site clinical unit in Prague and a recently opened 36-bed unit in Ostrava, we provide comprehensive services w...
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Product Digital Governance
With new advanced technologies and new standards for Compliance and Cybersecurity, developing an intelligent network and infrastructure is a top level priority for Life Science businesses. Choose PQE Group’s all-in-one integrated solutions to coordinate your Corporate Digital Development.
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Product Cell-based Neutralization Assays
Experienced cell-based neutralizing antibody assay capabilities. Our experts, at our GLP/GCP compliant laboratory, evaluate each therapeutic, conduct tailored assay development and ensure that each assay is optimized to suitably determine the presence of NAb with maximum possible level of drug toleran...
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Product R & D Laser
A small and powerful manually operated tablet laser drilling and writing machine for products of all shapes and sizes. Accommodates tablets, capsules or soft gels and manages multiple recipes. From laser marking soft gels to laser drilling tablets for controlled release, it delivers consistent, high qualit...
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Product Clinical Supply Manufacturing
NCEs • Phase I-III formulation process development and clinical supply manufacturing Generic drugs
• BE sample manufacturing • Process Optimization
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Product Newport, a Cortellis solution
Newport, a Cortellis solution, which integratesmarket, API and patent data in a single, integrated source of intelligence.
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Product PharmaCircle Premium Database
PharmaCircle provides the broad and deep global coverage, and powerful search and analysis tools needed to answer challenging questions so you can uncover new opportunities and make informed decisions.
Key content and capabilities include:
• Pipeline & Products Intelligence • D...
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Product Elitech Tlog 100EL Digital Temperature Data Logger Reusable Temperature ...
Elitech Tlog 100EL Temperature Data Logger Reusable Ultra Low Temperature Recorder is used to monitor and record the temperature for foods, pharmaceuticals, dry ice and other products during their storage and transport, and in each stage of cold chain logistics, such as refrigerated contain-ers/ truck...-comp323269.png)
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Product Pharmacovigilance - PvEdge - AI Enabled Drug Safety Database Suite
AI-enabled, cloud-ready,360 pharmacovigilance solution for safety database management. An end-to-end globally compliant safety software for Drugs, Devices, Vaccines and Combinational products from case intake to submissions and reporting. • Case Intake • Case Processing • Case Submission • Risk Manage...
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Product EMVS Connector
Platform for FMD 2D codes generation, CMO integration, 2D codes uploading to EMVS
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Product InSyBio Personalization Test
InSyBio Personalization Test is a tailor made machine learning-solution solution for each company allowing customers to quantify the benefits from using particular nutraceutical, vitamin and other food products. Around this test we have developed and provide a complete set of services to differentiate prod...
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Product IT/EU REGULATORY AFFAIRS - Support and management of Technical documenta...
OP Pharma has been providing innovative services in the Regulatory Affairs field for more than 20 years to small to big pharma Companies in Italy as well as in the European Union.
Our expertise covers the lifecycle management of pharmaceutical products, whole or in part, ranging from digitization ...
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Product DataCollector - High performance IT Infrastructure for Manufacturing
The plus10 DataCollector provides a high-performance data infrastructure for the acquisition and pre-processing of machine data from any source such as sensors, machine or robot controllers. Its simple configuration and implementation transforms machine data into Big Data and creates value through high-fre...
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Product Orphan Drug Development
Accelerating orphan drug development from candidate selection to commercial manufacture and supply.
With over 300 million people worldwide living with identified rare diseases, the development of new treatments to address these unmet clinical needs is an area of great interest in the pha...
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Product Product Realization Without Boundaries
As one of the largest contract development and manufacturing organizations (CDMO), the global footprint and rapid production capabilities of Phillips-Medisize allow customers to get to market faster and with more confidence. Combining Molex’s global scale in electronics with the design and manufacturing st...
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Product Cortellis Clinical Trials Intelligence™
Confidently and efficiently plan and design clinical trials by reducing time spent compiling and analyzing protocols, sites, outcomes, endpoints and more. Avoid costly protocol amendments, recruitment delays and trial failure by tracking competitive trials, selecting experienced sites, defining the right e...
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Product Drug Product Development
We support our clients from early-stage research and preclinical phase to and beyond market approval by providing comprehensive development services, including
• Developability assessment • Pre-formulation screening • Formulation development • Lyophilization process development • Forced d...
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Product Custom Protein Synthesis
We provide a Custom Protein Synthesis Service, using a chemical method that synthesises proteins amino acid by amino acid and making modifications on an atomic-scale. We work closely with our partners in designing, customising and optimising the proteins that is synthesized in an automa...
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Product CRO and CDMO Solutions
CRO and CDMO solutions: Transforming the pharmaceutical value chain for emerging biotechs and large pharmas - How integrating research and manufacturing processes enhances efficiency and accelerates time to market.
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Product Drug Product Manufacturing Service
Ardena offers services under brand pharmavize which includes drug product manufacturing service. It can manufacture various dosage forms, including: solutions and (nano-)suspensions, powder and granule filled capsules, semi-solid and, liquid filled capsules, topical products, tablets, modified-release prod...
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Product Microbiology
• Sterility Testing • Quality Control Release • Bioburden Testing • Method Suitability • Microbial Identification - MALDI-TOF • Bacterial Endotoxin Testing • Cytotoxicity • Environmental Monitoring • Biological Indicator Enumeration
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Product TIM-2
The TIM-2, as part of the SurroGUT™ platform, is the dynamic in vitro model of the large intestine. The lower GI model, with its anaerobic compartment containing highly metabolic active intestinal microbiota, precisely mimics the physiological conditions of the colon in vivo. TIM-2 can simulate the pr...
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Product Clinical Manufacturing
KBI Biopharma offers a broad range of cGMP biologics manufacturing services to biopharmaceutical companies worldwide. Our capabilities include reliable manufacturing for preclinical and clinical supply.
KBI’s experienced team produces high-quality therapeutics and vaccines thro...
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Product BDD Scintigraphy
Gamma scintigraphy is a powerful and versatile technology used to investigate the in-vivo performance of your drug or product. This non-invasive imaging technique allows us to follow the fate of the dosage form and administering it to a volunteer or patient. Not limited to just oral dosage forms, gamma sci...
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Product GCP Services
We offer a range of GCP services, from monitoring to audits. Providing comprehensive GCP compliance services for the pharmaceutical industry is one of our specialties.
A. Risk-Based Monitoring:
✔ Risk-Based Monitoring for Bioequivalence/Bioavailability Studies (BE...
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Product Integrated Services
Huayi Pharmaceuticals offers an integrated service for product development with our partners Weida Clinical Research and Velocyte Analytical Technology for your bioequivalence needs in China. Through these close strategic partnerships, we are able to offer a one-stop service which allows pharmaceutical dev...
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Product Medical Device Testing
1) Physico-Chemical Testing of Raw Material & Finished Medical Devices2) Biocompatibility Testing of Medical Devices(As per ISO 10993-1:2018)
3) Biological Testing of Raw Material of Plastic, Rubber,Silicone, Polymers, etc.(As per IP / BP / EP / JP / USP)
4) Microbiological Testing Services ...
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Product GCP Services(Good Clinical Practices)
We offer various GCP services which can help the clients across globe, ranging from audits to monitoring services. We provide comprehensive GCP Quality Compliance services to the pharmaceutical industry. Our GCP consulting services are characterized by:
1) Knowledge: Various regulatory requi...
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Product R&D Services
Our R&D Services are categorized into 8 streams: • Material Science Services
• Metal and Organic Scavenging Screening Services
• Organic Synthesis Services
• Catalysis Services
• Process Services
• Chromatography and Purification Services
• Method D...
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Product Drug efficacy, In vitro and in vivo studies
We offer a full range of studies and bioanalytical services, providing powerful tools and rigorous solutions for preclinical drug development of therapeutic candidates, advance lead compounds towards first-in- human trials, and support for ongoing clinical development
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Product Pre-Clinical Services
Our 3 platforms available are: • Solubility • Solid Dispersion • Nanoparticles
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Product Manufacturing Services
At Sharp, we work closely with you to build an in-depth understanding of your goals, challenges and requirements before we begin our state-of-the-art manufacturing process. This enables us to tailor our clinical manufacturing services to meet your specific needs, making sure we deliver your product on time...
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Product Certified toxicological studies
Toxicological tests performed at the Lukasiewicz - IPO:
-allow a toxicological evaluation of chemical substances contained in pharmaceutical products, veterinary medicinal products, plant protection products, food and feed additives, industrial chemical substances, etc.,
-make it possi...
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Product Clinical Trial Services
Our experts will accomplish your clinical objectives by leading the way from recruitment strategies, site selection, and clinical logistics, all the way through the regulatory process.
We use our own eClinical suite to be more cost-efficient and keep you connected remotely acros...
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Product Clinical Pharmacology
When you are looking for a partner who is dedicated to Phase I trials and early clinical development, rely on Quotient Sciences for the experience and expertise to seamlessly deliver your studies with the highest quality service and speed. We accelerate your molecule from first-in-human to proof-of-concept...
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Product Netpharmalab Consulting Services
Contract Research Laboratory. Analytical Services (physicochemical analysis, microbiological analysis and stability studies) and EU Import Lab.
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Product Preclinical Functional Neuroimaging
neuroPhINDr is our answer to the problem of low translational value of preclinical neuroimaging. With neuroPhINDr, we aim to shorten time-to-market, increase confidence in preclinical results and improve success rates in phase I trials. neuroPhINDr is a set of highly optimised and standardised protocols fo...
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Product Clinical Trial Design
Study design is a significant phase of any clinical research project. At Atlantia we feel that our careful planning and guidance to our clients coupled with our extensive experience with regulation, pre diseased and diseased populations, is what brings our clients back time and again to trust us with their...
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Product CRO Services
Clinical Development Program (Phase I to IV) Product Registration
Pharmacovigilance
Regulatory Affairs
Clinical Monitoring
Medical Monitoring
Project Management
Medical Writing
Quality Assurance - GCP Audits
Logistics Coordination
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Product UNITYai.Lit
Elevate your literature management with Unityai.Lit - the advanced software platform and the ultimate solution for efficient and validated ICSR processing and identification of publications for signaling and aggregate reports. Developed by Soterius, Inc., Unityai.Lit is not just a tool; it's a transformati...
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Product tiny-TIMsg
The tiny-TIMsg system, as part of the SurroGUT™ platform, precisely mimics the upper GI tract and all physiologically relevant processes; including the pressure, shear forces and phase specific gastric emptying. The tiny-TIMsg consists of an advanced gastric compartment (TIMagc) and small intestine co...
Position your company at the heart of the global Pharma industry with a CPHI Online membership
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Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
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Generate high-quality, engaged leads for your business, all year round
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Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
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Your company’s profile boosted at all participating CPHI events
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An easy-to-use platform with a detailed dashboard showing your leads and performance