Press Release

ELC Group launches new 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

 

Cambridge, UK, February 21 2012 - 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.”

To sign up online for a priority demonstration, please visit: http://www.pharmaereport.com

---ends---

Press contacts


Nicky Denovan
Pharma eReport
nicky [at] pharmaereport [dot] com
Phone: +44 (0) 7747 017654

About Pharma eReport (http://www.pharmaereport.com)
Cambridge, UK-based Pharma eReport 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 (http://www.elc-group.com)
ELC GROUP 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.


Please let us know any comments you have on this article:

Also see our

press coverage

News Index

05 Oct 2018

EU/US MRA - Brief overview and update

21 Aug 2018

Brexit - has the music stopped?

13 Jul 2018

Recent EMA Brexit Survey

15 Jun 2018

The EMA: 100 not out

08 May 2018

MHRA sets its post-Brexit strategic direction

12 Apr 2018

Brexit - Stick or Twist?

20 Mar 2018

Clinical Trials: all change 2019

22 Jan 2018

Orphan Medicines: almost 20 years on

15 Dec 2017

Update on Brexit developments

05 Oct 2017

How recent moves by the FDA spell good news for generics in the US

11 Sep 2017

Medicines for the Elderly – is your drug development strategy up to the mark?

14 Aug 2017

The MNAT initiative – what’s new?

19 Jul 2017

ICH Q12: Light at the end of the tunnel…?

05 Jun 2017

Q3D: Are your established products in compliance?

02 Jun 2017

Key pharmacovigilance trends to watch

08 May 2017

EMA updates guidance on PSURs

10 Apr 2017

New EMA Consultation on the Quality of Inhaled Pharmaceutical Products

16 Mar 2017

European Parliament’s adoption of ‘Options for improving access to medicines’ procedure

16 Feb 2017

Article 58: a hidden potential

24 Jan 2017

Global lifesciences partner ELC Group teams with PSR Group for advanced drug development

19 Jan 2017

A positive step forward for Biosimilar registration

20 Dec 2016

Falsified Medicines Directive – Are you making the right preparations?

21 Nov 2016

New Public consultation launched by the European Commission (EC)

19 Oct 2016

Transatlantic collaboration to boost research and development of medicines for rare diseases

03 Jun 2016

ELC Group to showcase regulatory affairs solutions at CPhI events in Shanghai and Barcelona

16 Jun 2015

ELC Group in early-stage development of novel influenza vaccine

09 Jun 2015

ELC Group expands into pharmaceutical product development market

21 Apr 2015

ELC Group signs 1.5 million Euro regulatory affairs contract with Chinese pharma giant

24 Feb 2015

Fast-growing regulatory affairs service provider ELC Group expands corporate presence in Czech Republic

02 Feb 2015

ELC GROUP to present at “Regulatory & Legal Affairs in Russia 2015” Conference

15 Sep 2014

Pharma eReport delivers V5-compliant solution to help MAHs meet December 31st XEVMPD resubmission deadline

20 Aug 2014

ELC Group Appoints Dr. Siddharth Chachad as Head of Global Clinical Development and Medical Affairs

28 Jul 2014

ELC Group Appoints Head of Regulatory Affairs for Russia and CIS

14 Apr 2014

Global regulatory affairs specialist ELC Group appoints Localization Business Development Manager for new US Office

10 Oct 2013

Global regulatory affairs specialist ELC Group accelerates international expansion plans following 25% revenue growth in 2013

17 Sep 2013

Global regulatory affairs specialist ELC Group appoints former MHRA Expert Medical Assessor

23 Apr 2013

Global regulatory affairs specialist ELC Group receives accreditation to provide readability testing in Romania

27 Feb 2013

Global regulatory affairs specialist ELC Group to deliver pharmaceutical training event in Latvia

20 Feb 2013

Global pharmaceutical regulatory affairs specialist ELC Group launches Clinical Trials services

10 Jan 2013

Global pharmaceutical regulatory affairs specialist ELC Group hosts International Training Seminar in Mumbai, India

31 Dec 2012

2012 Events

07 Nov 2012

Global pharmaceutical regulatory affairs specialist ELC Group establishes new office in Singapore

22 Aug 2012

Global pharmaceutical regulatory affairs specialist ELC Group increases operational support in Ahmedabad

12 Jun 2012

XEVMPD software provider Pharma eReport launches Excel Data Import Service

06 Jun 2012

ELC Group partners with mdi Europa GmbH to offer end-to-end regulatory solution for medical device companies in Europe

28 Mar 2012

ELC Group joins DIA EuroMeeting in Copenhagen

21 Mar 2012

EVMPD software provider Pharma eReport announces full general availability of Centrality XEVMPD compliance solution

08 Mar 2012

ELC Group Hosts Successful International Regulatory Seminar

06 Mar 2012

Pharmaceutical regulatory affairs specialist ELC Group opens new office in Mumbai

23 Feb 2012

Regulatory challenges for 2012 and their impact on marketing authorisation

21 Feb 2012

ELC Group launches new software subsidiary Pharma eReport to provide complete EVMPD compliance solution

08 Feb 2012

Pharmaceutical regulatory affairs specialist ELC Group establishes global HQ in Cambridge, UK

07 Dec 2011

Past president of TOPRA and ELC GROUP Advisor speaks at International Regulatory Seminar in Ahmedabad 23 February 2012

27 Sep 2011

ELC GROUP Advisory Board’s Dr. Paolo Biffignandi to write opinion column for industry leading publication

12 Jul 2011

ELC Group aim to foster strategic and economic ties within India and China

25 May 2011

ELC Group announces doubled revenues

11 May 2011

ELC Group appoints former TOPRA President