Press Coverage

Mutually beneficial — worksharing makes pan-Atlantic product launches easier
21st December 2017 epm
epm

One of the potential pitfalls when preparing a product launch is planning for GMP inspections. An upside of recent events, the FDA confirming that eight EU member states have at least equivalent capabilities as the FDA in performing GMP inspections, is worksharing, leading towards a more globalised market. In this article Vikash Patel, senior regulatory specialist for ELC Group, tells us more…


»Read the full article

The impact of pharmacovigilance on the public health environment
25th October 2017 epm
epm

Pharmacovigilance is a dynamic clinical and scientific discipline that has had an important impact on the public health environment. Madalina Huruba, manager (Pharmacovigilance), ELC Group, goes into the history of the discipline and the necessity of an effective pharmacovigilance system.


»Read the full article

Practically popular — outsourcing could offer a practical approach to drug development
13th September 2017 epm
epm

As pressure to get drugs to the human clinical trial stage increases more companies are looking to outsource not only non-core functions but major areas of R&D. Here, Praveen C. Surana, senior director of Business Development, ELC Group, examines outsourcing projects in more detail.


»Read the full article

Making it in America: Post-authorisation challenges for pharma
23rd March 2017 epm
epm

Many pharmaceutical companies in unregulated markets which are sufficiently large will eventually expand internationally, especially to the United States and European Union. The US and EU remain two of the most lucrative markets for pharmaceutical products, and dossiers approved in these territories are highly sought after due to their high quality compared to dossiers from unregulated markets. A marketing authorisation (MA) approval from the US/ EU can also boost confidence in the products of the companies involved.


»Read the full article

Going global: How pharma is adopting to globalisation
14th February 2017 epm
epm

Asia’s pharmaceutical sector is experiencing significant growth following recent merger and acquisition activity of pharmaceutical companies, aimed at exploiting the intensity of competition in the Asian pharmaceutical market. It is truly a new era of globalisation for Asia’s pharmaceutical companies looking to expand their markets internationally.


»Read the full article

Safety first: Guiding medical device safety
26th December 2016 epm
epm

The regulatory landscape of medical devices is changing in sync with the overall global regulatory requirements, which are in a period of rapid change.  The US recently finalised its guidance on “ISO 10993 and Biological Evaluation of Devices”, which includes details of risk-based biocompatibility approaches, chemical assessment and biocompatibility test article preparations for devices utilising nanotechnology.


»Read the full article

The importance of data integrity in the pharmaceutical sector
28th October 2016 epm
epm

Integrity in its true sense is applicable in every walk of life and the pharmaceutical industry is no exception. In recent years, health regulators all over the world have come up with guidelines, certifications, rules and regulations for the effective implementation of cGMP practices in pharmaceutical manufacturing. Essentially, cGMP guidance and regulations allow flexible and risk-based approaches to address product specific needs.


»Read the full article

Medical Device Regulations In Latin America And The Way Forward
14th July 2016 Medtech Insight
Medtech Insight

Akhila Krishnan reviews the different regulatory requirements for medical devices in five Latin American countries and discusses how harmonization initiatives will make things easier for manufacturers in this guest column.


»Read the full article

Medical device regulation: an overview
22nd February 2016 EPM
EPM

The medical device industry is a crucial part of the healthcare sector. The global medical device market is expected to reach $440 billion by 2018, growing at about 4.4% per year. Contrast that with the prescription drug market, predicted to grow at an annual rate of 2.5%. Established players in this industry include the United States and Western Europe. But industry trends show that Asia and importantly, China are about to play a prominent role in the next few years.


»Read the full article

Medicine in Europe: what are the barriers?
4th February 2016 EPM
EPM

Access to medicine and return on investment have always been key public policy considerations for governments to balance increasing healthcare cost and promote innovation.


»Read the full article

News Index

26 Nov 2018

Industry plans for disruption amid Brexit uncertainty

25 Oct 2018

ELC Group at 5th Nordic Pharmacovigilance Day - Oct 24th, Copenhagen

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