regulatory affairs Latest News

SFL is pleased to announce the constitution of its company Advisory Board.

SFL's Managing Director invited to speak at biotech workshop in Germany

SFL team showcase expertise in Regulatory Affairs, Public Affairs, Legal Services and Medical Communications at the 2013 DIA Annual EuroMeeting in Amsterdam.

Shayesteh Fürst-Ladani, SFL’s Managing Director, will give a presentation on the classification and regulation of drug/device combinations at the MEDTEC Europe event to be held in Stuttgart, Germany from 26 to 28 February 2013.

SFL’s team to provide delegates with an understanding of the regulatory framework for drug/device combinations and drug/companion diagnostics in the EU

Badri Rengarajan, M.D., Medical Director, will present in the modeling and simulation tools to improve Phase III success session.

ELC Group approved by Romanian Medical Agency (NAMMD) to conduct Patient Information Leaflet (PIL) Readability Testing for products targeting Romanian market

SFL is pleased to announce the constitution of its company Advisory Board.

SFL's Managing Director invited to speak at biotech workshop in Germany

SFL team showcase expertise in Regulatory Affairs, Public Affairs, Legal Services and Medical Communications at the 2013 DIA Annual EuroMeeting in Amsterdam.

ELC Group experts speaking at two-day seminar dedicated to marketing authorisation holders and regulatory affairs professionals

ELC Group now offering comprehensive range of consultancy and support services for clinical trials

Shayesteh Fürst-Ladani, SFL’s Managing Director, will give a presentation on the classification and regulation of drug/device combinations at the MEDTEC Europe event to be held in Stuttgart, Germany from 26 to 28 February 2013.

Unique two-day training event will deliver expert updates on latest European and South Asian regulatory landscape

Interview with Cheryl Shea-Frederick, Director, Regulatory Affairs at ArthroCare Corporation

ELC Group boosts support for customers across South East Asian region with new regional office

Interview with Tatyana Chorny, Regulatory Affairs, Post-Market Surveillance & Complaints Management at Philips Healthcare

SFL Regulatory Affairs & Scientific Communication Ltd (SFL) has been selected as a finalist in the 2012 British-Swiss Business Awards.

Shayesteh Fürst-Ladani, Managing Director of the SFL will speak on European Day at the World Medtech Forum in Lucerne, Switzerland.

SFL’s team to provide delegates with an understanding of the regulatory framework for drug/device combinations and drug/companion diagnostics in the EU

ELC Group continues Indian expansion with move to new, larger offices in key regional centre

All medical device manufacturers are required to comply with the complaint handling requirements and medical device reporting (MDR) pursuant to the applicable statutes and regulations.

ELC Group expands India presence with new operation at heart of world’s largest pharmaceutical hub

Leading provider of Oracle's clinical trial, data, and dug safety software will discuss why and how Empirica Topics should be implemented and used to strengthen an organization’s pharmacovigilance systems and processes.

Opening of new global base follows year of exceptional revenue growth

Badri Rengarajan, M.D., Medical Director, will present in the modeling and simulation tools to improve Phase III success session.

Synowledge is a global provider of drug safety, regulatory affairs and related IT solutions to small, mid and large sized pharmaceutical and biotechnology companies.

The Educational Services division of UK based MNC,Helix Research Center has announced Clinical Research Certificate Courses with 6 months Internship for the Life Sciences aspirants in all major cities in India

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

Africa Health Research Organisation and Helix Research Center have announced Clinical Research Training Programs for the Life Sciences Aspirants and Corporates in the Africa and Europe

Sentrx, the leading provider of drug safety services to the life sciences industry, is pleased to announce the promotion of Michael O’Gorman from CFO to President & General Manager, effective immediately.

World-renowned physician Dr. Paolo Biffignandi joins ELC GROUP’s Advisory Board

Manufacturers and registration holders of traditional herbal medicinal products (THRs) agreed to join forces in an association whose functions would include campaigning for the safety of herbal medicinal products.

Leading provider of Oracle’s clinical trial, data, safety, and pharmacovigilance systems will discuss the new Individual Case Safety Report (ICSR) international standard and upcoming reporting changes, and how to comply with them using Argus Safety

Regulatory Resources Group (RRG), Surrey, England recently won the support category at the inaugural Regulatory Affairs Awards ceremony during a Gala Dinner at the TOPRA Annual Symposium in London.

Educational Services Division of UK based MNC,Helix Research Center has announced Coorespondence Certificate Courses in Clinical Reseatch for the Doctors,Nurses,CRAs,CRCs and Life Sciences Aspirants seeking Careers in Clinical Research Worldwide

UK based MNC,Helix Research Center has announced CRO and GCP Training Services for the Global Biopharmaceutical,Medical Device ,Cosmetic Industry,WHO,NIH etc and Clinical Reseatch Professionals respectively in BRICS Nations

Portugal based Yabulu and United Kingdom based Helix Research Center Ltd have announced Pharmacovigilance Training Programs,both for Freshers as well as working Professionals Worldwide.

Helix Research Center Ltd has announced Clinical Research Corporate Training Offerings Worldwide ,for Pharmaceutical,Biotechnology,Medical Device and Cosmetic companies ,Investigative Sites,Ethics Committees ,Govt ,Non Govt bodies doing Research.

"These short term training programs are quite helpful for the professionals and students in the clinical research and quality assurance field, who can't attend regular training programs.",said Mr.Kamal Shahani, Director Cliniminds.

Samantha Ng, Senior Recruitment Consultant joins CK Clinical heading up the Regulatory Affairs recruitment Team. Having worked in the Pharmaceutical recruitment field since 2003, Sam is a real asset to the team.

Pharmacovigilance gaining in importance after Vioxx problems-our new report analyses post-marketing assessment from the present onwards-Pharmacovigilance has been expanding in recent years, as companies are required to monitor drug safety post launch

CK Clinical are now using Twitter to keep job seekers and candidates up to date with vacancies as soon as they come in

Natural Health, Beauty and Personal Care Products consultant Idea MKT Solutions launches its new corporate image at www.ideamktsolutions.com

Troubled e-clinical specialist Datatrak International (Cleveland, Ohio) could be up for sale shortly, depending on the outcome of a review of strategic options now under way.

In the latest of five acquisitions, Worldwide Clinical Trials (Beverley Hills, California) has completed the purchase of Serbian CRO MediQuest (Belgrade).

Canadian CRO Algorithme Pharma (Laval, Quebec) has acquired a US clinical research centre from Bioanalytical Systems (BASi - West Lafayette, Indiana) for US$850,000 in cash.

US e-clinical specialist Datatrak International (Cleveland, Ohio) has decided to close its office in Bonn, Germany. Global help-desk services previously carried out by the office will now be provided from the company’s Cleveland headquarters.

Report Buyer, the online destination for business intelligence for major industry sectors, has added a new report offering invaluable information about the pharmaceutical regulatory affairs in the EU and US.

Today a small delay in gaining market access means huge loss in terms of market share and revenue generated. The key to success for pharmaceutical companies lies in obtaining timely marketing approval from regulators.Regulatory Affairs Outsourcing...

Regulatory Affairs consulting agency launches new website for marketing their outsourced compliance and regulatory affairs services targeting pharmaceutical, healthcare, biotech and medical companies.

Veeda Oncology (Columbus, Ohio) has acquired French cancer trials specialist Biologie et Industrie for an undisclosed sum.

Quintiles Transnational (Research Triangle Park, North Carolina) has signed an agreement to acquire Eidetics (Boston, Massachusetts), a privately held healthcare market research and consulting firm. Financial terms were not disclosed.

Pharmaceutical services company i3 (Basking Ridge, New Jersey) has acquired Russian CRO Lege Artis (Moscow). Financial terms were not disclosed.

Mixed results for Novartis’s first-in-class direct renin inhibitor, Rasilez (aliskiren), have been reported from the ALLAY study at the American College of Cardiology meeting in Chicago, US.

Parexel International (Boston, Massachusetts) has sold its stand-alone bioanalytical laboratory in Poitiers, France, to privately owned Indian CRO Synchron Research Services (Ahmedabad, Gujarat)