PharmaCircle provides global content, analytics, and visualization tools covering the pharmaceutical, biotechnology, and drug delivery industries through its Premium Service platform which offers extensive proprietary data, analysis, and visualizations across various modules to help users in R&D, clinical, regulatory, and other areas of these industries with their research and decision-making. The Premium Service offers over 120,000 products and candidates in development, analytical tools, custom data services, and support from a team of industry analysts to provide a comprehensive single source of information.
ISO IDMP: Practical considerations from XEVMPD experienceQdossier B.V.
ISO IDMP (Identification of Medicinal Products) is coming! What lessons can we learn from our practical exprience with XEVMPD in preparation for IDMP? Topics include data cleaning, managing inconsistencies across product registrations and countries and controlled vocabularies
Leveraging Oracle IDMP Enterprise Foundation Suite for Regulatory CompliancePerficient, Inc.
IDMP (Identification of Medicinal Products), which will soon be mandated by the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA), will enable stakeholders to obtain a comprehensive view of each individual product (e.g., ingredients, marketing and medicinal information, contacts), based on unique codes.
While the journey towards IDMP compliance can be incredibly challenging, industry-specific knowledge and systems play an integral role in meeting the new requirements.
In our webinar, we discussed how the Oracle IDMP Enterprise Foundation Suite can help you be ready in time.
The introduction of Identification of Medicinal Products (IDMP), as developed by the International Organization for Standardization (ISO), marks the next phase of evolution for the European drug dictionary project under Article 57.
The European Medicines Agency (EMA) will issue guidance based on five documents published by the ISO, which will require life sciences companies to use a "set of common global standards for data elements, formats, and terminologies for the unique identification and exchange of information on medicines."
Complying with IDMP represents a massive increase in scope and complexity, in addition to previous iterations. The EMA has divided the timeline for meeting the new requirements into several phases, making this a multi-year project.
Perficient’s expert in IDMP and the EudraVigilance Medicinal Product Dictionary, Mark Thackstone, reviewed everything you need to know in order to successfully comply with IDMP by the fast-approaching deadline:
-Latest information and timelines
-Steps to take meet regulatory requirements
-Challenges and factors to consider
-What IDMP means in the real world of a typical pharma company
Pfizer, GE Healthcare, Novartis Pharma and Boehringer-Ingelheim Pharma Confir...Torben Haagh
Want to learn more about how to cover gaps for IDMP implementation until July 1st 2016? Then join experts at the International Conference IDMP Implementation - Impact on Data, Systems and Processes taking place in Berlin from 24 – 25 June 2015.
There are limited places available, so make sure you secure your conference ticket today! Learn more here.
Don't miss this unique opportunity to hear expert presentations, take part in interactive workshops and meet with IDMP experts from around the world including participation from:
• Pfizer Inc. • Boehringer-Ingelheim Pharma GmbH & Co. KG • F. Hoffmann-La Roche Ltd. • Marr Consultancy Ltd • GE Healthcare • A.E.Tiefenbacher GmbH & Co. KG • Bundesinstitut für Arzneimittel und Medizinprodukte • Bundesverband der Arzneimittel-Hersteller e.V. • MEDA Pharma GmbH & Co. KG • Mylan EPD, Inc. • Janssen Pharmaceuticals, Inc. • Novartis Pharma AG and many more.
Want to know more regarding this topic area? Then join us at our
IDMP Implementation - Impact on Data, Systems and Processes
24 – 25 June 2015 | Steigenberger Hotel Berlin, Germany
For more information take a look at our agenda here: http://bit.ly/IDMP_agenda
Or visit our website: http://bit.ly/IDMP_website
Building a link between ectd and xevmpdQdossier B.V.
Describing the role of XEVMPD/ IDMP in context of the regulatory environment and explaining the link with information managed within the eCTD and under GMP.
ISO IDMP: Practical considerations from XEVMPD experienceQdossier B.V.
ISO IDMP (Identification of Medicinal Products) is coming! What lessons can we learn from our practical exprience with XEVMPD in preparation for IDMP? Topics include data cleaning, managing inconsistencies across product registrations and countries and controlled vocabularies
Leveraging Oracle IDMP Enterprise Foundation Suite for Regulatory CompliancePerficient, Inc.
IDMP (Identification of Medicinal Products), which will soon be mandated by the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA), will enable stakeholders to obtain a comprehensive view of each individual product (e.g., ingredients, marketing and medicinal information, contacts), based on unique codes.
While the journey towards IDMP compliance can be incredibly challenging, industry-specific knowledge and systems play an integral role in meeting the new requirements.
In our webinar, we discussed how the Oracle IDMP Enterprise Foundation Suite can help you be ready in time.
The introduction of Identification of Medicinal Products (IDMP), as developed by the International Organization for Standardization (ISO), marks the next phase of evolution for the European drug dictionary project under Article 57.
The European Medicines Agency (EMA) will issue guidance based on five documents published by the ISO, which will require life sciences companies to use a "set of common global standards for data elements, formats, and terminologies for the unique identification and exchange of information on medicines."
Complying with IDMP represents a massive increase in scope and complexity, in addition to previous iterations. The EMA has divided the timeline for meeting the new requirements into several phases, making this a multi-year project.
Perficient’s expert in IDMP and the EudraVigilance Medicinal Product Dictionary, Mark Thackstone, reviewed everything you need to know in order to successfully comply with IDMP by the fast-approaching deadline:
-Latest information and timelines
-Steps to take meet regulatory requirements
-Challenges and factors to consider
-What IDMP means in the real world of a typical pharma company
Pfizer, GE Healthcare, Novartis Pharma and Boehringer-Ingelheim Pharma Confir...Torben Haagh
Want to learn more about how to cover gaps for IDMP implementation until July 1st 2016? Then join experts at the International Conference IDMP Implementation - Impact on Data, Systems and Processes taking place in Berlin from 24 – 25 June 2015.
There are limited places available, so make sure you secure your conference ticket today! Learn more here.
Don't miss this unique opportunity to hear expert presentations, take part in interactive workshops and meet with IDMP experts from around the world including participation from:
• Pfizer Inc. • Boehringer-Ingelheim Pharma GmbH & Co. KG • F. Hoffmann-La Roche Ltd. • Marr Consultancy Ltd • GE Healthcare • A.E.Tiefenbacher GmbH & Co. KG • Bundesinstitut für Arzneimittel und Medizinprodukte • Bundesverband der Arzneimittel-Hersteller e.V. • MEDA Pharma GmbH & Co. KG • Mylan EPD, Inc. • Janssen Pharmaceuticals, Inc. • Novartis Pharma AG and many more.
Want to know more regarding this topic area? Then join us at our
IDMP Implementation - Impact on Data, Systems and Processes
24 – 25 June 2015 | Steigenberger Hotel Berlin, Germany
For more information take a look at our agenda here: http://bit.ly/IDMP_agenda
Or visit our website: http://bit.ly/IDMP_website
Building a link between ectd and xevmpdQdossier B.V.
Describing the role of XEVMPD/ IDMP in context of the regulatory environment and explaining the link with information managed within the eCTD and under GMP.
How to Review, Cleanse, and Transform Clinical Data in Oracle InFormPerficient, Inc.
When it comes to clinical trials, the consequences of bad data can be severe. Research and development becomes complicated and lives can be put at risk. The need for clinical data to be clean is critical for comprehensive reporting and analysis, ultimately enabling safer drugs and devices to be brought to market faster.
During our 30-minute, no-nonsense webinar, we discussed why and how organizations can leverage Oracle Health Sciences Data Management Workbench (DMW) to revitalize the clinical trial data captured in Oracle Health Sciences InForm.
IDMP Implementation - Impact on Data, Systems and Processes. How to cover gap...Torben Haagh
ISO IDMP will be mandatory from July 1st 2016 and it will make a fundamental impact on the way the pharmaceutical industry is required to collect, manage and submit relevant data. Now is the last call for all marketing authorisation holders to (re)think their data submission policies and processes to make sure you close your IDMP implementation gaps in the next 12 month and have a clear vision of the next challenges lying ahead!
Don’t miss out on the opportunity to get your questions answered, to benchmark the stage of your preparation, to initiate partnerships and to take an active part in designing the RIM’s community future agenda! Join us this summer in Berlin and gain valuable, practical information:
# Learn how to assess and analyse data requirements for the IDMP standards by discussing possible interpretations with our expert from regulatory bodies on-site!
# Benchmark your own IDPM Implementation process with peers from both big and mid-size pharma
# Share insights how the IDMP standards are changing the interactions between IT-Systems, company departments, contract manufacturers and regulatory agencies
# Discuss and compare with your peers experiences with vendors and solution providers offering help to achieve your IDMP implementation goals!
For more information visit our website: http://bit.ly/EventWebsite
If you would like to be part of the conference, you can register now here: http://bit.ly/Register-Event
The presentation complemented a 60 minutes webinar on ISO IDMP provided by Cunesoft in May 2015. Benefits of a regulatory master data management system are being analyzed. The entire webinar was recorded. The latest information on IDMP can be accessed on our website: https://www.phlexglobal.com/idmp
Pharma & Medical Devices Industry Research & Analysis | ArancaAranca
Aranca supports several global pharmaceutical and medical device companies with business research & market intelligence on new products & markets, competitor activities, regulatory environment, innovation trends, product pipelines and supply chain efficiency
http://MedicalDeviceEvents.com At the 10x Medical Device Conference in 2014, presenters Carrie Kuehn, Jorge Ochoa, and Robert Packard explained why, according to data from FDA, more than 58% of 510(k) submissions were refused under FDA’s Refuse to Accept (RTA) policy during its first year of implementation.
This presentation examined some of the reasons why industry got such a bad “grade.” We discussed the RTA requirements and some of the challenges from industry’s perspective on meeting the requirements of the RTA checklist and ended with recommendations on how industry can improve its odds of getting past the RTA hurdle on the first try.
Myriad genetics, inc. product pipeline analysisraja1233
Companyprofilesandconferences.com glad to promote a new report on "Myriad Genetics, Inc. (MYGN) - Product Pipeline Analysis" which is a source for data, analysis, and actionable intelligence on the company’s portfolio of pipeline products who provides key information about the company, its major products and brands.
Incorporating Commercial and Private Data into an Open Linked Data Platform f...Alasdair Gray
The Open PHACTS Discovery Platform aims to provide an integrated information space to advance pharmacological research in the area of drug discovery. Effective drug discovery requires comprehensive data coverage, i.e. integrating all available sources of pharmacology data. While many relevant data sources are available on the linked open data cloud, their content needs to be combined with that of commercial datasets and the licensing of these commercial datasets respected when providing access to the data. Additionally, pharmaceutical companies have built up their own extensive private data collections that they require to be included in their pharmacological dataspace. In this paper we discuss the challenges of incorporating private and commercial data into a linked dataspace: focusing on the modelling of these datasets and their interlinking. We also present the graph-based access control mechanism that ensures commercial and private datasets are only available to authorized users.
http://link.springer.com/chapter/10.1007/978-3-642-41338-4_5
During our 45-minute webinar, Pooja Jain outlines the following:
- How your peers are using Pharmapendium to successfully move drugs along the pipeline.
- How you can be “Better informed” and what this really means to you and your colleagues.
The impact on information flow, safety and labelling documents, document granularity, naming of documents and metadata, the preparation and submissions of XEVMPD dossiers
Our introductory PharmaPendium webinar shows you:
- How your peers are using Pharmapendium to successfully move drugs along the pipeline.
- How you can be “Better informed” and what this really means to you and your colleagues.
Merck & co., inc. barclays final 3-10-2015Marcel Brussee
What does Merck's $10B buyback plan say about pharma M&A?
Adding $10 billion to its stock buyback program might mean Merck & Co. ($MRK) wants to keep investors happy as its sales continue to shrink. That would be the typical explanation. But The Wall Street Journal sees a different possibility--one the rest of the industry might want to pay attention to.
Source: http://www.fiercepharma.com/story/what-does-mercks-10b-buyback-plan-say-about-pharma-ma/2015-03-26?utm_campaign=SocialMedia
I woke up the other day and my watch said 8:54 PM, a sure sign of a dead battery. Later that day I took the watch to the Fast Fix location in the local mall. The customer service representative told me that a new battery would be about $20 and then he went on to tell me that there were various other prices that I could pay that would include a warranty. I told him just to put in the new battery for the $20 fee.
How to Review, Cleanse, and Transform Clinical Data in Oracle InFormPerficient, Inc.
When it comes to clinical trials, the consequences of bad data can be severe. Research and development becomes complicated and lives can be put at risk. The need for clinical data to be clean is critical for comprehensive reporting and analysis, ultimately enabling safer drugs and devices to be brought to market faster.
During our 30-minute, no-nonsense webinar, we discussed why and how organizations can leverage Oracle Health Sciences Data Management Workbench (DMW) to revitalize the clinical trial data captured in Oracle Health Sciences InForm.
IDMP Implementation - Impact on Data, Systems and Processes. How to cover gap...Torben Haagh
ISO IDMP will be mandatory from July 1st 2016 and it will make a fundamental impact on the way the pharmaceutical industry is required to collect, manage and submit relevant data. Now is the last call for all marketing authorisation holders to (re)think their data submission policies and processes to make sure you close your IDMP implementation gaps in the next 12 month and have a clear vision of the next challenges lying ahead!
Don’t miss out on the opportunity to get your questions answered, to benchmark the stage of your preparation, to initiate partnerships and to take an active part in designing the RIM’s community future agenda! Join us this summer in Berlin and gain valuable, practical information:
# Learn how to assess and analyse data requirements for the IDMP standards by discussing possible interpretations with our expert from regulatory bodies on-site!
# Benchmark your own IDPM Implementation process with peers from both big and mid-size pharma
# Share insights how the IDMP standards are changing the interactions between IT-Systems, company departments, contract manufacturers and regulatory agencies
# Discuss and compare with your peers experiences with vendors and solution providers offering help to achieve your IDMP implementation goals!
For more information visit our website: http://bit.ly/EventWebsite
If you would like to be part of the conference, you can register now here: http://bit.ly/Register-Event
The presentation complemented a 60 minutes webinar on ISO IDMP provided by Cunesoft in May 2015. Benefits of a regulatory master data management system are being analyzed. The entire webinar was recorded. The latest information on IDMP can be accessed on our website: https://www.phlexglobal.com/idmp
Pharma & Medical Devices Industry Research & Analysis | ArancaAranca
Aranca supports several global pharmaceutical and medical device companies with business research & market intelligence on new products & markets, competitor activities, regulatory environment, innovation trends, product pipelines and supply chain efficiency
http://MedicalDeviceEvents.com At the 10x Medical Device Conference in 2014, presenters Carrie Kuehn, Jorge Ochoa, and Robert Packard explained why, according to data from FDA, more than 58% of 510(k) submissions were refused under FDA’s Refuse to Accept (RTA) policy during its first year of implementation.
This presentation examined some of the reasons why industry got such a bad “grade.” We discussed the RTA requirements and some of the challenges from industry’s perspective on meeting the requirements of the RTA checklist and ended with recommendations on how industry can improve its odds of getting past the RTA hurdle on the first try.
Myriad genetics, inc. product pipeline analysisraja1233
Companyprofilesandconferences.com glad to promote a new report on "Myriad Genetics, Inc. (MYGN) - Product Pipeline Analysis" which is a source for data, analysis, and actionable intelligence on the company’s portfolio of pipeline products who provides key information about the company, its major products and brands.
Incorporating Commercial and Private Data into an Open Linked Data Platform f...Alasdair Gray
The Open PHACTS Discovery Platform aims to provide an integrated information space to advance pharmacological research in the area of drug discovery. Effective drug discovery requires comprehensive data coverage, i.e. integrating all available sources of pharmacology data. While many relevant data sources are available on the linked open data cloud, their content needs to be combined with that of commercial datasets and the licensing of these commercial datasets respected when providing access to the data. Additionally, pharmaceutical companies have built up their own extensive private data collections that they require to be included in their pharmacological dataspace. In this paper we discuss the challenges of incorporating private and commercial data into a linked dataspace: focusing on the modelling of these datasets and their interlinking. We also present the graph-based access control mechanism that ensures commercial and private datasets are only available to authorized users.
http://link.springer.com/chapter/10.1007/978-3-642-41338-4_5
During our 45-minute webinar, Pooja Jain outlines the following:
- How your peers are using Pharmapendium to successfully move drugs along the pipeline.
- How you can be “Better informed” and what this really means to you and your colleagues.
The impact on information flow, safety and labelling documents, document granularity, naming of documents and metadata, the preparation and submissions of XEVMPD dossiers
Our introductory PharmaPendium webinar shows you:
- How your peers are using Pharmapendium to successfully move drugs along the pipeline.
- How you can be “Better informed” and what this really means to you and your colleagues.
Merck & co., inc. barclays final 3-10-2015Marcel Brussee
What does Merck's $10B buyback plan say about pharma M&A?
Adding $10 billion to its stock buyback program might mean Merck & Co. ($MRK) wants to keep investors happy as its sales continue to shrink. That would be the typical explanation. But The Wall Street Journal sees a different possibility--one the rest of the industry might want to pay attention to.
Source: http://www.fiercepharma.com/story/what-does-mercks-10b-buyback-plan-say-about-pharma-ma/2015-03-26?utm_campaign=SocialMedia
I woke up the other day and my watch said 8:54 PM, a sure sign of a dead battery. Later that day I took the watch to the Fast Fix location in the local mall. The customer service representative told me that a new battery would be about $20 and then he went on to tell me that there were various other prices that I could pay that would include a warranty. I told him just to put in the new battery for the $20 fee.
Los pórticos ISL se caracterizan por ser unas máquinas robustas, capaces de mover cargas tanto vertical como horizontalmente, ya sean de grandes dimensiones o estrechas. Esta máquina se puede fabricar a medida, especialmente la altura, la anchura y la distancia entre ejes, según las necesidades del cliente.
Los pórticos grúa SL son unos modelos más estrechos que los ISL, pero son capaces de transportar grandes cargas. Este sistema SL no tiene capacidad de mover estas cargas de forma horizontal.
Para más información envíe un e-mail a info@almarin.es
Se analizan y comparan las distribuciones de 1970 y 1971 desde la perspectivas de las clases medias de bienestar. Las estimaciones de consumo de los hogares se expresan a precios constantes por medio de indices de preciso estadisticos. Se analiza con posterioridad un nuevo concepto denominado (x,)-desigualdad y se desarrollan procedimientos operativos que permiten aplicar este concepto intermedio a un caso empirico concreto: la evolucion del bienestar economico en españa durante de decada de los 80. Se tratan a continuacion los temas de la desigualdad intermedia y paretiana.
Finalmente se aborda el problema de la pobreza en nuestro pais. Se aplican los procedimientos de inferencia estadistica existentes en el campo de la desigualdad.
Cada capitulo incluye un apartado de conclusiones.
Case study marki Hexeline z Albumu Superbrands Polska 2008Superbrands Polska
Misją marki Hexeline jest dążenie do wypracowania unikalnego stylu kolekcji poprzez oferowanie Klientkom produktów tworzonych z myślą o kształtowaniu wyczucia klasycznej elegancji z odrobiną nonszalancji. Kolekcje Hexeline są autorskimi projektami Haliny Zawadzkiej – założycielki i głównej projektantki firmy. Dzięki jej obserwacji światowych trendów, wyczuciu potrzeb kobiet i nieograniczonej wyobraźni powstają ujmujące elegancją i oryginalnym krojem kreacje.
Identifying Safety Signals by Data Mining the FDA Adverse Event Reporting Sys...Perficient, Inc.
Ever since the European Union (EU) introduced new legislation that requires life sciences companies to proactively detect, prioritize, and evaluate safety signals, there has been an increased interest, not only from sponsors and CROs in the EU, but globally, in pharmacovigilance systems that can assist with the signal management process.
Perficient's Chris Wocosky, an expert in signal detection and management, shows how your organization can use Empirica Signal, Oracle's state-of-the-art signal detection system to data mine the existing FDA Adverse Event Reporting System (FAERS) to determine safety signals. This presentation and demonstration willhelp you bettter understand how this solution can be used in daily pharmacovigilance activities.
Accuscript Pharmacovigilance Service - Literature Monitoring & Social Media D...Ajay Francis Christopher
- Global (via Embase & PubMed), Local journal & Social Media Literature Search
- Social Media Data mining (sentiment analysis of drugs)
- Review of literature search hits relevant for AE reporting/safety information
- Developing ready-to-use ICSR narratives
- QC of ICSRs.
Similar to PharmaCircle Capabilities Presentation 2016 (20)
Accuscript Pharmacovigilance Service - Literature Monitoring & Social Media D...
PharmaCircle Capabilities Presentation 2016
1. Global Content, Analytics and Visualization Tools for
Pharmaceutical, Biotechnology and Drug Delivery
Professionals
The Difference Is In The Details
3. PharmaCircle Product Portfolio Scope
2003 –
Drug delivery and formulation
technology information
2016 –
Full complement of research,
development, clinical, business
and regulatory modules for drug
and combination products,
biologicals, devices and more
Global coverage of RX, OTC,
Generic and Veterinary products
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not available elsewhere
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a single source
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Industries
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Development
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Broad and unique data and analysis under a single service
40+ search modules covering pipeline, clinical trials, regulatory, formulation/drug
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and component details
Provides detailed information on 5,500+ Drug Delivery technologies and the
associated products by 300+ Drug Delivery categories.
Developed and supported by a global team of analysts
Easy to use search tools and detailed results
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7. Premium Service: Information Sources
• Daily news
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other countries
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32,000+ Japan Products
36,000+ Canada Products
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63,900+ FDA Approval Documents
14,900+ FDA Warning Letters
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Data Validation and Enhancement:
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much more by our global team of analysts provides vital insight
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decision support
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