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最新新闻

17.09.2021 |

ELC

新冠疫情下欧盟GMP官方认证激活策略及审计趋势

于2021年9月23日（星期四）北京时间晚上20：00， ELC将举办一场关于“新冠疫情下欧盟GMP官方认证激活策略及审计趋势”的中文线上讲座，为各位同仁分享我们的GMP审计经验，欢迎大家报名参与！ 本次讲座的主讲人为 Chetan Javia —— ELC集团战略联盟与法规事务总监，以及杨思琪女士 —— ELC集团商务总监。 此次讲座我们将和大家分享以下几个话题： 1. 欧盟GMP法规概况 2. 欧盟GMP认证申请的途径 3. 疫情对于欧盟GMP审计的影响 4. 欧盟官方的相应对策 此次讲座为免费讲座，但人数有限。 请点击报名， 我们将发送讲座详情及接入码至您的邮箱，请点击

30.07.2021 |

ELC

业内动态 | 药政领军咨询企业ELC集团成为法国PLG集团的一员，正式解锁120个国家的市场准入服务

各位同仁，在此我们很荣幸地向大家宣布一条关于 ELC 集团的重要消息。 经过长久的努力，今日ELC集团与ProductLife Group (PLG)正式签署并购协议，成为这家法国全球法规咨询集团的一员。 自 2004 年以来，ELC 一直致力于满足客户在全球市场，从产品开发到法规获批、生命周期维护的一站式支持。 过去的 17 年是一段难忘的发展旅程。今日，我们很高兴加入 PLG，进一步增强我们欧洲、北美、中东、亚洲、非洲和拉丁美洲等国家的资源和能力。 此前，PLG的员工遍布 40 个国家/地区，并在全球 110 多个国家建立了广泛的运营网络。PLG 在其他领域的广泛专业知识将进一步优化我们为客户提供的服务。 此后，ELC集团将与PLG强强联手，继续支持我们的客户，特别是我们的中国和亚洲客户们，为大家的全球市场扩张和发展提供更好的平台。我们的能力将进一步扩展，尤其是针对美国市场的创新药、生物技术、医疗器械、警戒系统和医疗信息以及 CMC 审计。 在此，我们想感谢各位同仁一直以来的支持和关注！期待未来我们能有更深更广的合作！ 详情请查看此处的正式公告。 We are proud to share an update on a major development of ELC Group with you. We are now officially part of ProductLife Group (PLG), a Global Life Science Consultancy […]

09.11.2020 |

ELC

欧盟临床事务浅谈：如何优化您的临床策略和实验

于2020年11月12日（星期四）北京时间晚上20：00， ELC将举办一场关于“欧盟临床事务浅谈：如何优化您的临床策略和实验”的中文线上讲座，为各位同仁分享我们的临床策略经验，欢迎大家报名参与！ 本次讲座的主讲人为 Marco Rubinstein —— ELC集团CEO，以及曾妮女士 —— ELC集团资深商务经理。 此次讲座我们将和大家分享以下几个话题： 新特药欧盟临床策略 欧盟药监局科学建议会 临床试验的管理 临床数据的整合和呈现 此次讲座为免费讲座，但人数有限。 请点击报名， 我们将发送讲座详情及接入码至您的邮箱，请点击  

18.06.2020 |

ELC

ELC欧盟准入讲座预告

应中国合作伙伴的要求，ELC将举办一场关于欧洲市场准入的讲座，与大家分享从MA持有角度，看进入欧盟市场的要求。 会议时间：北京时间2020年06月30号，晚上19:00 主讲人： Marco Rubinstein – CEO 杨思琪 – ELC集团商务总监 报名参加，请填写以下信息，我们将发送讲座详情和接入码至您邮箱。

08.10.2018 |

ELC

ELC Group at 5th Nordic Pharmacovigilance Day

We are pleased to be attending and sponsoring the 5th Nordic Pharmacovigilance Day in Copenhagen, Denmark on Wednesday October 24th 2018.  The 5th Nordic Pharmacovigilance Day provides an opportunity to learn more about latest developments in Pharmacovigilance (PV) and engage with peer members of industry, regulators and service providers. The event focuses on major topics […]

05.10.2018 |

ELC

EU/US MRA – Brief overview and update

Since 2003, the EMA and the US FDA have had confidential agreements in place in order to allow for the exchange of confidential information for regulatory and scientific purposes. As part of this arrangement there is also a Mutual Recognition Agreement (MRA) in relation to GMP inspections. The agreements cover a range of topics including […]

21.08.2018 |

ELC

Brexit – has the music stopped?

As we fast approach October, when supposedly the UK Government is to finalise and agree with the EU its Brexit strategy, we seem no closer to an actual answer as to what will happen post 30th March 2019. On the one hand, we have the MHRA recently stating that an implementation period that takes us […]

13.07.2018 |

ELC

Recent EMA Brexit Survey

Back in January 2018, the EMA launched a survey to all companies that held a centrally authorised product. The survey was intended to understand the level of preparedness in relation to Brexit. A summary of the survey is as follows. The EMA received a high response rate of around 90% of the 180 companies they […]

15.06.2018 |

ELC

The EMA: 100 not out

Earlier this month, the EMA management board held its landmark 100th board meeting. The meeting was the last to be held at its current Headquarters in Canary Wharf in London, and brought together the former chairs of the Board as well as Executive Directors. Usually getting to a centenary in any walk of life is […]

08.05.2018 |

ELC

MHRA sets its post-Brexit strategic direction

Last month, the Medicines and Healthcare Products Regulatory Agency (MHRA) released its 5-year corporate plan (2018 – 2023). Naturally, with Brexit fast approaching in the rear-view mirror, there has been much anxiety and uncertainty within the industry as to what direction the MHRA will plan to take. The plan outlines the agency’s strategic direction over […]

12.04.2018 |

ELC

Brexit – Stick or Twist?

The EU Commission is working on overdrive at present to encourage pharma companies to take heed of the looming Brexit deadline.Last month, Brexit arrived at the all-important 12-month mark until inception, and the EU commission is concerned that MA holders are taking a far too reactive approach to the situation by not choosing to initiate […]

20.03.2018 |

ELC

Clinical Trials: all change 2019

For the last 18 years, clinical trials in the EU have been governed by the Clinical Trails Directive. The directive itself was seen at the time as a major milestone in ensuring more transparent and structured regulations relating to clinical trials. However, as time has moved and the landscape regarding clinical trials has changed, an […]

22.01.2018 |

ELC

Orphan Medicines: almost 20 years on

The EU orphan medicine scheme has been in place since 2000, with the principle aim to encourage companies to develop medicines for rare diseases. According to EU statistics, there are over 6,000 rare diseases and approximately 30 million people sufferers. Due to the lack of readily available therapies, treating these patients has always presented a […]

15.12.2017 |

ELC

Update on Brexit developments

These days there doesn’t seem to be a day that goes by where there isn’t some snippet of news on the great Brexit plan. Obviously, something of such magnitude has ramifications across all sectors of life. Naturally the regulatory aspects of drug registration and life cycle management are areas that will require very careful planning […]

05.10.2017 |

ELC

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

On October 2nd 2017, the FDA held a 2-day meeting to discuss how generic drug development – especially that for complex generics – could be better streamlined. The FDA has clearly noticed that competition in the complex generic space is increasingly slow and hard to generate and, as such, it has released two new draft […]

11.09.2017 |

ELC

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

On 1st August 2017, the EMA (European Medicines Agency) launched a public consultation into the possible avenues via which medicines for the elderly may be developed. This reflection paper is aimed at bringing together the available evidence and to support discussion on the development of medicinal products for this key patient population. At this point […]

14.08.2017 |

ELC

The MNAT initiative – what’s new?

Back in 2013, the European Medicines Agency (EMA) established a pilot scheme called the Multinational Assessment Team (MNAT) Initiative. For the assessment of new marketing authorisation applications, the MNAT provides the option for the EMA scientific committees to rely on an assessment team formed from national competent authorities (NCAs) of different European Union (EU) Member […]

19.07.2017 |

ELC

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

Lifecyle management has always taken the lion share of resources for any regulatory department – both in terms of time and costs. The ICH Q12 guideline is meant to facilitate the management of post-approval changes in a more productive and efficient manner, thus helping both regulators and pharma companies alike manage their resources more effectively. […]

05.06.2017 |

ELC

Q3D: Are your established products in compliance?

Here are ELC Group, we pride ourselves of providing our clients with the latest regulatory intelligence and tools for managing an ever-evolving regulatory landscape. One such example is compliance with the ICH guideline Q3D elemental impurities. The guideline was adopted by the CHMP in December 2014 and has come into effect for all new applications […]

02.06.2017 |

ELC

Key pharmacovigilance trends to watch

The pharmacovigilance space continues to evolve at a rapid pace, with the emergence of new technologies, increased data sources, and changing global regulatory requirements adding to the pressures and responsibilities for pharmacovigilance professionals. In this article, we explore three key issues that are impacting pharmacovigilance practice: 1. Access to EudraVigilance data – EudraVigilance Data Analysis […]

08.05.2017 |

ELC

EMA updates guidance on PSURs

For the past 2 years the EMA has been monitoring nationally authorised medicines via the single assessment of periodic safety update reports (PSURs). Based on collective feedback from their experience, the agency has now published recommendations as part of its commitment to continuous process improvement. Companies know only too well that the majority of their […]

10.04.2017 |

ELC

New EMA Consultation on the Quality of Inhaled Pharmaceutical Products

It has been a long held understanding within the pharmaceutical industry that the registration of inhaled pharmaceutical products has been somewhat challenging, especially with regard to generic filings. These issues have mainly centred around the quality section of the dossier and therapeutic equivalence. Recently, the European Medicines Agency (EMA) began a consultation on planned changes […]

16.03.2017 |

ELC

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

On March 2nd 2017, the European Parliament voted to adopt “EU options for improving access to medicines 2016/2057(INI)”. The procedure places generic, biosimilar and value-added medicines at the heart of the debate on access to medicines. Specifically, the report calls for Member States to encourage competition from generic and biosimilar medicines by removing barriers and […]

16.02.2017 |

ELC

Article 58: a hidden potential

In 2004, the EMA introduced the Article 58 procedure to help increase access to medicines by low- and middle-income countries and to improve public health. Article 58 was borne from a collaboration with the World Health Organisation (WHO) to get much needed medicines such as vaccines to those countries in most need. Over the years, […]

24.01.2017 |

ELC

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

ELC Group selects Pharma Scientific Research (PSR Group) for initial commission of 10 new products Cambridge, UK, 24th January 2017: Global life sciences partner ELC Group is teaming with New Zealand-based research and development company Pharma Scientific Research (PSR Group) to create highly advanced products for the pharmaceutical market. Under the initial terms of the […]

19.01.2017 |

ELC

A positive step forward for Biosimilar registration

It has been a long established idea that, since the European Union (EU) approval of the first biosmilar way back in 2006, progress in this area has been more troublesome than first anticipated. To date, there have only been 26 biosimiliar approvals, and an often erratic approach to acceptance and substitution within the individual member […]

20.12.2016 |

ELC

Falsified Medicines Directive – Are you making the right preparations?

With the Falsified Medicines Directive (FMD) coming into effect from February 9, 2019, the spotlight is on the pharmaceutical industry to be better prepared for compliance with the enhanced security requirements. Current Landscape The current numbers are truly disturbing, with an approximate annual death toll of 100,000 from falsified and counterfeit medicines, according to the […]

21.11.2016 |

ELC

New Public consultation launched by the European Commission (EC)

On 15th November, the EC launched a public consultation to get views and feedback from stakeholders, to support the Commission in drafting its second report on the Paediatric Regulation. The launch of this consultation comes exactly 10 years after the first consultation. The consultation will be open for 5 days and feedback will be centralised […]

19.10.2016 |

ELC

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

A new working group (“cluster”) has been set up by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), with the aim of sharing experiences and best practices in relation to the regulatory approach taken for the development of medicines for rare diseases. Historically, the main hurdle faced by companies wishing […]

03.06.2016 |

ELC

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

June 3rd 2016 – ELC Group announces that it will be exhibiting at two major upcoming CPhI events this year – CPhI China in Shanghai from June 21st – 23rd 2016 and CPhI Worldwide in Barcelona, Spain, from October 4th – 6th. CPhI China is the most comprehensive purely pharma-focused event for domestic and international […]

16.06.2015 |

ELC

ELC Group in early-stage development of novel influenza vaccine

1 million Euro project marks regulatory affairs provider’s entry into pharmaceutical development market Cambridge, UK, 16th June, 2015 – ELC Group, one of the fastest-growing providers of regulatory affairs services, today announces that it has signed up for the early-stage development of a novel vaccine targeting prevention of influenza. The project signals ELC Group’s entry […]

09.06.2015 |

ELC

ELC Group expands into pharmaceutical product development market

Fast-growing regulatory affairs provider creating extensive product portfolio for sale across US, EU, LATAM, MENA and China Cambridge, UK, 9th June, 2015 – ELC Group, one of the fastest-growing providers of regulatory affairs services, today announces that it is expanding into the pharmaceutical development market with the creation of an extensive product portfolio targeting a […]

21.04.2015 |

ELC

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

Landmark deal ELC Group’s Concept to Commercialisation solution approach Cambridge, UK, 21 April, 2015 – ELC Group, one of the fastest-growing providers of regulatory affairs services, today announces that it has been awarded a 1.5 million Euro contract by one of China’s biggest pharmaceutical companies. The contract award is a major endorsement of ELC Group’s […]

24.02.2015 |

ELC

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

Major contract wins in China and US fuel latest move into larger premises in Prague Cambridge, UK, 24th February, 2015 – ELC Group, one of the fastest-growing providers of regulatory affairs services, today announces that it is expanding its office presence in Prague in the Czech Republic due to accelerating company growth. From May, ELC […]

02.02.2015 |

ELC

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

Dr. Parvinder Punia, Senior regulatory expert will present “European experience of harmonising the pharmaceutical market” at Moscow conference on February 10th 2015 Cambridge, UK, 2nd February, 2015 – ELC Group, one of the fastest-growing providers of regulatory affairs, today announces that its Senior Regulatory Affairs Manager Dr Parvinder Punia will be an invited speaker at […]

15.09.2014 |

ELC

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

Centrality software is fully compliant with EMA V5 schema updates and available now to pharmaceutical Marketing Authorisation Holders Cambridge, UK, September 15th 2014 – Pharma eReport, a software and services company that delivers a comprehensive XEVMPD compliance solution for pharmaceutical regulatory professionals, today announces that its Centrality software is fully compliant with the latest XEVMPD […]

20.08.2014 |

ELC

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

Internationally acclaimed clinical pharmacologist joins global regulatory affairs specialist in key management post Cambridge, UK, 20 August, 2014 – ELC Group, one of the fastest-growing providers of regulatory affairs, today announces the appointment of internationally acclaimed clinical pharmacologist Dr. Siddharth Chachad as Head of Global Clinical Development and Medical Affairs. A member of the UK […]

28.07.2014 |

ELC

ELC Group Appoints Head of Regulatory Affairs for Russia and CIS

Inna Demidova to head new Moscow office for fast-growing global regulatory affairs specialist Cambridge, UK, 28 July, 2014 – ELC Group, one of the fastest-growing providers of regulatory affairs, today announces the appointment of Inna Demidova as a Senior Regulatory Affairs Expert for Russia and the Commonwealth of Independent States (CIS). Previously with Ferring Pharmaceuticals […]

14.04.2014 |

ELC

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

ELC Group expands delivery of language translation and localization services to North and South American markets with opening of Philadelphia office Cambridge, UK, April 14, 2014 – ELC Group, one of the fastest-growing providers of regulatory affairs, today announces the appointment of Suzanne Morris as Localization Business Development Manager for North America, heading up its […]

10.10.2013 |

ELC

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

Record revenue growth during first nine months of the year leads to new office openings in Brazil, Russia and China Cambridge, UK, 10 October, 2013 – ELC GROUP, one of the fastest-growing providers of regulatory affairs consulting services, today announces that it has achieved 25% year-on-year revenue growth in the first nine months of 2013 […]

17.09.2013 |

ELC

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

World-renowned clinical scientist John Warren joins ELC GROUP’s Advisory Board Cambridge, UK, 17th September, 2013 – ELC GROUP, one of the fastest-growing providers of regulatory affairs consulting services, today announced that John Warren, a former Expert Medical Assessor for the UK Medicines Healthcare products Regulatory Agency (MHRA) has joined the ELC GROUP Advisory Board. John […]

23.04.2013 |

ELC

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

ELC Group approved by Romanian Medical Agency (NAMMD) to conduct Patient Information Leaflet (PIL) Readability Testing for products targeting Romanian market Cambridge, UK, 23rd April, 2013 – ELC GROUP, one of the fastest-growing providers of regulatory affairs consulting services, today announces that the National Agency for Medicines and Medical Devices (NAMMD) has issued ELC Group […]

27.02.2013 |

ELC

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

ELC Group experts speaking at two-day seminar dedicated to marketing authorisation holders and regulatory affairs professionals Cambridge, UK, 27th February 2013 – ELC GROUP, one of the fastest-growing providers of regulatory affairs consulting services, today announces that it will be hosting a two-day seminar from 13th – 14th March 2013 in Riga, Latvia. The exclusive […]

20.02.2013 |

ELC

Global pharmaceutical regulatory affairs specialist ELC Group launches Clinical Trials services

ELC Group now offering comprehensive range of consultancy and support services for clinical trials Cambridge, UK, February 20 2013 – ELC GROUP, one of the fastest-growing providers of regulatory affairs consulting services, today announces the launch of a new Clinical Trials service for pharmaceutical customers worldwide. The new end-to-end service offering spans Bioavailability/Bioequivalence (BA/BE) and […]

10.01.2013 |

ELC

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

Unique two-day training event will deliver expert updates on latest European and South Asian regulatory landscape Cambridge, UK, 10th January 2013 – ELC GROUP, one of the fastest-growing providers of regulatory affairs consulting services, today announces that it will be hosting a two-day international training seminar from 28th February – 1st March 2013 in Mumbai, […]

31.12.2012 |

ELC

2012 Events

ELC Group will be attending the following international events during 2012. If you would like to book a meeting at any of these shows with the ELC Group team, please contact sales [at] elc-group [dot] com. Medtech Europe, 13th – 15th March 2012, Stuttgart, Germany Hong Kong International Medical Devices and Supplies Fair, 7th – […]

07.11.2012 |

ELC

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

ELC Group boosts support for customers across South East Asian region with new regional office Cambridge, UK, November 7th 2012 – ELC GROUP, one of the fastest growing providers of regulatory affairs consulting services, today announces the opening of a new operational office in Singapore, its first in the region. The new office will bolster […]

22.08.2012 |

ELC

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

ELC Group continues Indian expansion with move to new, larger offices in key regional centre Cambridge, UK, August 22nd 2012 – ELC GROUP, the global pharmaceutical regulatory affairs organisation, today announces that it has established new, larger offices in Ahmedabad, India, to support its continued growth in the region. The new Ahmedabad office will host […]

12.06.2012 |

ELC

XEVMPD software provider Pharma eReport launches Excel Data Import Service

New “Collate, Convert & Comply” service imports, checks and converts Microsoft Excel Spreadsheet data to compliant XML format Cambridge, UK, June 12th 2012 – Pharma eReport, a software and services company that delivers a comprehensive EVMPD compliance solution for pharmaceutical regulatory professionals, today announces the launch of its “Collate, Convert & Comply” Excel spreadsheet data […]

06.06.2012 |

ELC

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

Preferred Partnership delivers complete consultancy support and expertise – from device registration to CE marking Cambridge, UK, June 6 2012 – ELC GROUP, the pan-European pharmaceutical regulatory affairs organisation, today announces that it has formed a preferred European partner relationship with mdi Europa GmbH, a global regulatory consultancy for medical device and IVD companies. The […]

28.03.2012 |

ELC

ELC Group joins DIA EuroMeeting in Copenhagen

Parvinder Punia and Pooja (Rai) Telavane – General Manager, Regulatory Affairs, of ELC Group’s new Mumbai office – will be representing ELC Group at the upcoming DIA EuroMeeting in Copenhagen (26 – 28 March 2012). The EuroMeeting attracts more than 3,000 professionals from over 50 countries, bringing together professionals from the biopharmaceutical industry, contract service […]

21.03.2012 |

ELC

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

Centrality software is fully compliant with March 2012 EMA specification updates and available now to pharmaceutical Marketing Authorisation Holders Cambridge, UK, March 21 2012 – Pharma eReport, a software and services company that delivers a comprehensive EVMPD compliance solution for pharmaceutical regulatory professionals, today announces that its Centrality software suite is now in full general […]

08.03.2012 |

ELC

ELC Group Hosts Successful International Regulatory Seminar

ELC Group shared the very latest developments in regulatory affairs with delegates at its successful International Regulatory Seminar in Ahmedabad, India on February 23rd 2012. The full-day training event was hosted by Past President of TOPRA and ELC Group Advisor Dr. Paolo Biffignandi (MD, PhD, QPPV, FTOPRA) and addressed regulatory challenges for 2012 and their […]

06.03.2012 |

ELC

Pharmaceutical regulatory affairs specialist ELC Group opens new office in Mumbai

Cambridge, UK, March 6 2012 – ELC GROUP, the pan-European pharmaceutical regulatory affairs organisation, today announces that it has opened a new office in Mumbai, India. The Mumbai operation will be staffed with a senior regulatory affairs team and expands ELC Group’s presence in India, adding to the Group’s successful regional base in Gujarat. The […]

23.02.2012 |

ELC

Regulatory challenges for 2012 and their impact on marketing authorisation

INTERNATIONAL SEMINAR – 23 February 2012 in Ahmedabad Come join us in Ahmedabad and expand your expertise pool! REGULATORY CHALLENGES FOR 2012: OVERVIEW OF LATEST CHANGES IN THE EUROPEAN REGULATORY PROCEDURES VARIATIONS REGULATION – THE NEW ELEMENTS EUDRAVIGILANCE CHANGES: IMPLEMENTATION OF ELECTRONIC SUBMISSION OF MEDICINAL PRODUCT INFORMATION IN THE EU (ARTICLE 57(2) REQUIREMENTS OF THE […]

21.02.2012 |

ELC

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 […]

08.02.2012 |

ELC

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

Cambridge, UK, February 8 2012 – ELC GROUP, the pan-European pharmaceutical regulatory affairs organisation, today formally announces that it has established its global headquarters in Cambridge, UK. The opening of the new global HQ follows a year of exceptional revenue growth for ELC Group, and strengthens ELC Group’s ability to serve customers across its major […]

10.01.2012 |

ELC

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

Unique two-day training event will deliver expert updates on latest European and South Asian regulatory landscape Cambridge, UK, 10th January 2013 – ELC GROUP, one of the fastest-growing providers of regulatory affairs consulting services, today announces that it will be hosting a two-day international training seminar from 28th February – 1st March 2013 in Mumbai, […]

07.12.2011 |

ELC

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

Cambridge, UK, December 7th 2011 – ELC GROUP, the pan-European pharmaceutical regulatory affairs organisation, today announces that it will be hosting an international training seminar on 23rd February 2012 in Ahmedabad, India. The event will address the regulatory challenges for 2012 and their impact on marketing authorisation. As well as an overview of the latest […]

27.09.2011 |

ELC

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

September 27th 2011 – ELC GROUP, the pan-European pharmaceutical regulatory affairs organisation, announced today that it would be working with the editorial team of European Pharmaceutical Manufacturer magazine to supply expert opinion on the regulatory affairs industry. ELC GROUP’s Advisory Board member, Dr. Paolo Biffignandi MD, PhD, QPPV, FTOPRA, will write the regular column. Dr. […]

12.07.2011 |

ELC

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

July 12th 2011 – ELC GROUP, the pan-European pharmaceutical regulatory affairs organisation, announced today that its experts would be visiting China and India next month to boost partnerships and discuss future collaborations with leading regional pharmaceutical companies. The visit to China comes on the back of ELC GROUP’s recent consultation work with one of the […]

25.05.2011 |

ELC

ELC Group announces doubled revenues

May 25th 2011 – ELC GROUP, the pan-European pharmaceutical regulatory affairs organisation announced today a total revenue increase of 94% for the first quarter of 2011. ELC Group published their annual results in January and predicted a gain in net revenues for the first quarter of 2011. The resulting increase is higher than expected and […]

11.05.2011 |

ELC

ELC Group appoints former TOPRA President

World-renowned physician Dr. Paolo Biffignandi joins ELC GROUP’s Advisory Board May 11, 2011 – ELC GROUP, the pan-European pharmaceutical regulatory affairs organisation, today announced that former President of The Organisation for Professionals in Regulatory Affairs (TOPRA), Dr. Paolo Biffignandi MD, PhD, QPPV, FTOPRA has joined the ELC GROUP Advisory Board. Dr. Biffignandi is a world-renowned […]

11.05.2011 |

ELC

Industry plans for disruption amid Brexit uncertainty

With the EMA’s relocation to Amsterdam showing no signs of becoming painless, the European Parliament’s health committee has signaled its intention to review the governance of agencies as an opportunity to ensure it plays an active role in future decisions. This stance has come from members of the Committee on the Environment, Public Health and […]
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