PRTODAY / NewswireToday Free press release distribution service network

Written by / Agency / Source: NeonDrum Ltd

Check Ads Availability|e-mail Article


Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!

ELC Group Launches Software Subsidiary Pharma eReport to Provide Complete EVMPD Compliance Solution - Full software solution plus specialist support services offers pharmaceutical Marketing Authorisation Holders fastest route to meeting XEVMPD mandate - ELC-Group.com / PharmaeReport.com
ELC Group Launches Software Subsidiary Pharma eReport to Provide Complete EVMPD Compliance Solution

 

NewswireToday - /newswire/ - Reading, Berkshire, United Kingdom, 2012/02/21 - Full software solution plus specialist support services offers pharmaceutical Marketing Authorisation Holders fastest route to meeting XEVMPD mandate - ELC-Group.com / PharmaeReport.com.

   
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Pharma/BioTech/Nutrition Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

ELC Group, the pan-European pharmaceutical regulatory affairs organisation, today announces the launch of a new subsidiary, Pharma eReport – a software and services company that delivers a comprehensive EVMPD compliance solution for pharmaceutical regulatory professionals.

Pharma eReport offers a total package for Marketing Authorisation Holders (MAHs) seeking to meet the July 2nd 2012 deadline for mandatory EudraVigilance Medicinal Product Dictionary (EVMPD/XEVMPD) data submissions. With its flagship Centrality software suite and specialist EVMPD services – delivered by a Key Support Services team of qualified chemists – Pharma eReport provides a comprehensive EVMPD solution, including complete outsourced data-gathering and compilation of Structured Substance Information (SSI) libraries. The Centrality software is available as an on-demand software-as-a-service (SaaS)/cloud-based solution – accessed via a standard web browser – or it can be installed as a standalone software application. Centrality is offered via a transparent pricing model and will be in full general availability from March 2012. Prospective users are invited to sign up online now for priority product demonstrations.

Pharma eReport’s Centrality software tool allows MAHs to quickly and effortlessly convert existing medicinal product information into an XML Schema Definition (XSD)- compliant format, and seamlessly upload the required data as a EudraVigilance Product Report Message (EVPRM) using an approved submission mechanism. The software is secure, easy to use and custom-engineered for flexible implementation, including development support for bespoke interfaces to provide full harmonisation with customers’ existing systems.

Pharma eReport’s Centrality platform provides an intuitive product license management system for database-wide pharmacovigilance updates, tracking, organising and managing product and substance information, and ensuring continuing EMA regulatory compliance. Centrality can be coupled with specialist Key Support Services – including data collation, organisation and mapping capabilities, plus complete SSI library compilation services – to enable customers to extract maximum value from substance data.

Pharma eReport is co-founded by the management of ELC Group plus former executives from electronic design automation software company Synopsys, Inc. Pharma eReport harnesses the unparalleled industry knowledge of its regulatory expert founders and combines this with a world-class software development team to deliver a total solution for EVMPD compliance and beyond.

Commenting on the solution launch, Marco Rubinstein, CEO of ELC Group and Pharma eReport said: "We are launching our new subsidiary and the Centrality solution to deliver the full service solution that regulatory teams need to meet the time-critical EVMPD compliance challenge. We’ve designed a uniquely flexible, transparently-priced software solution which can be supported by our highly skilled service organisation of qualified chemists and, crucially, access to our key SSI library resources. For regulatory teams, we are reducing the admin burden and providing an easy-to-use software platform that creates a valuable centralised product license and information database for future use.” He continued: “Beyond the immediate 2012 deadline, all MAH submissions will soon need to comply with a coming ISO IDMP (Identification of Medicinal Products) standard, expected to be in force by 2015. So pharmaceutical companies that are selling or marketing medicinal products in Europe will need to implement an effective e-reporting solution now, to reduce the MAH submissions management overhead and ensure seamless ongoing regulatory adherence. We’re looking forward to becoming the industry’s key solution partner for EVMPD compliance – and beyond.”

Press contact
Nicky Denovan, Pharma eReport
E: nicky[.]pharmaereport.com - P: +44 (0) 7747 017654

About Pharma eReport
Cambridge, UK-based Pharma eReport (pharmaereport.com) provides intuitive electronic product data management and reporting software for pharmaceutical regulatory professionals.

With its flagship Centrality software suite and supporting specialist EVMPD services – delivered by a Key Support Services team of qualified chemists – Pharma eReport provides a comprehensive EVMPD solution, including complete outsourced data-gathering and compilation of Structured Substance Information (SSI) libraries. The Centrality software is available as an on-demand software-as-a-service (SaaS)/cloud-based solution – accessed via a standard web browser – or it can be installed as a standalone software application at a client site.

Pharma eReport is co-founded by the management of ELC Group, a leading global services company with recognised expertise in regulatory affairs and Marketing Authorisation management. Pharma eReport harnesses the unparalleled industry knowledge of its regulatory expert founders and combines this with a world-class software development team to deliver a total solution for EVMPD compliance and beyond.

About ELC Group
ELC Group (elc-group.com) is a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries as well as REACH services to the Chemical industry. It helps companies that lack the resource (skills and knowledge) to cost effectively deliver regulatory affairs.

ELC Group provides full-service, multi-lingual consulting and cost-effective solutions to regulatory approvals using experts with in-depth knowledge and experience throughout the world. The team ranges from former FDA investigators to individuals with over 30 years of industry experience with broad capabilities. This includes integrated advanced technologies, regulatory affairs consulting and commercialisation services.

 
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Pharma/BioTech/Nutrition Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Written by / Agency / Source: NeonDrum Ltd

 
 

Availability: All Regions (Including Int'l)

 

Traffic Booster: [/] Quick Newswire Today Visibility Checker

 

Distribution / Indexing: [+]

 
 
# # #
 

 
  Your Banner Ad showing on ALL
Pharma/BioTech/Nutrition articles,
CATCH Visitors via Your Competitors Announcements!


ELC Group Launches Software Subsidiary Pharma eReport to Provide Complete EVMPD Compliance Solution

Company website links NOT available to basic submissions
It is OK to republish and/or LINK any newswire for any legitimate media purpose as long as you name Newswire Today and LINK as the source.
 
  Is this your article?
Activate ALL web links and social stream by Upgrading to Press Release PREMIUM Plan Now!

|
Publisher Contact: Liz Hartney - NeonDrum.com 
+44(0)75 1051 8732 nicky[.]pharmaereport.com
 
Newswire Today - PRZOOM / PRTODAY disclaims any content contained in this article. If you need/wish to contact the company who published the current release, you will need to contact them - NOT us. Issuers of articles are solely responsible for the accuracy of their content. Our complete disclaimer appears here.
IMPORTANT INFORMATION: Issuance, publication or distribution of this press release in certain jurisdictions could be subject to restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with the applicable rules and regulations in the particular jurisdiction. This press release does not constitute an offer or an offering to acquire or subscribe for any NeonDrum Ltd securities in any jurisdiction including any other companies listed or named in this release.

Pharma/BioTech/Nutrition via RSSAdd NewswireToday - PRZOOM Headline News to FeedBurner
Find who RetweetFollow @NewswireTODAY



Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!


Read Latest Articles From NeonDrum Ltd / Company Profile


Read Pharma/BioTech/Nutrition Most Recent Related Newswires:

Frost & Sullivan Commends Nemaura for Developing Superior Transdermal Drug Delivery Technology Platforms, the Memspatch and Micropatch
Greenphire Sponsors Second Annual Clinical Trial Agreements, Investigator Payments and Fair Market Value Meeting
Genentech’s Gazyva Helped People with Previously Untreated Follicular Lymphoma Live Significantly Longer
BD Announces Adoption of Windows 10 ‘Internet of Things’ for the Pyxis™ ES System
Greenphire Named to Deloitte 2016 Technology Fast 500™
Genentech Showcases New Clinical Data Across a Variety of Blood Diseases at American Society of Hematology 2016 Annual Meeting
BD Collaborates with JDRF to Focus on Extended Wear Innovations for Insulin Infusion Delivery
BD Launches First Syringe Designed for Use with Humulin® R U-500 Insulin
MDxHealth Announces Unique CPT Code Awarded for ConfirmMDx from the American Medical Association
BD MAX™ Vaginal Panel Receives FDA Market Authorization to Detect Most Common Causes of Vaginal Infections
Greenphire Receives EU-US Privacy Shield Certification
The 2016 Georges Mathé Prize Recognizes Research on the Immunological Determinants of the Response to Breast Cancer Treatment
MDxHealth Announces Agreement with HIFU CLINIC Prostate Cancer Center for Distribution of SelectMDx in Poland
First Patient in Malaysia Receives TheraSphere™ Radioembolisation Therapy
FDA Approves Genentech’s Lucentis® (Ranibizumab Injection) Prefilled Syringe

Boost Your Social Network
& Crowdfunding Campaigns


LIFETIME SOCIAL MEDIA WALL
NewswireToday Celebrates 10 Years in Business


PREMIUM Members


Visit  La Bella Bakery Artisan Bakery Arizona

Visit  JobsWare.com





 
  ©2016 Newswire Today — Limelon Advertising, Co.
Home | About | Advertise/Pricing | Contact | Investors | Privacy/TOS | Sitemap | FRANCAIS
newswire, PR free press releases distribution service magazines engine news alert newsroom press room breaking news public relations articles company news alerts newswiredistribution ezine bizentrepreneur biznewstoday digital business report market search pr firms agencies reports distri-bution today investor relation successful internet entrepreneurs newswire distribution prtoday.com freenewswiredistribution asianewstoday bizwiretoday USA pr UK today - NOT affiliated with PRNewswire as we declined their partnership offer in 2013
 
PRTODAY & NewswireTODAY are NOT affiliated with USA TODAY (usatoday.com)