PharmaLex provides a PHLEX ible service approach.
The benefits to our clients of using our services:
PharmaLex recently completed the merger of McGee Pharma International (MPI).
“Being part of an international service provider enables us to provide existing clients with a wider range of services as well as support clients in new markets and locations”, said Ann McGee, Managing Director, McGee Pharma International, a PharmaLex Company. Ann will remain at the helm in Ireland and will continue to drive quality management and compliance (GxP) in both Ireland and Europe.
To watch MPI’s statement on the merger, click on the link to the right >>
Tissue, Cell And Gene Therapy Development
Engage with global decision makers and influencers in the biotechnology hub of 2018! Meet us at the DIA Global Annual Meeting 2018 at booth #1126
Meet us at the BIO International Convention 2018 at booth #1309
Meet us at the DIA Europe 2018 meeting at booth #106
Meet us at booth #18 or listen to Wenda Brennan discuss the benefits of artificial intelligence on adverse event monitoring on 10-11 April in Washington D.C..
Arrange a meeting with our experts at the DIA Regulatory Submission, Information, and Document Management Forum on 5-7 February in North Bethesda, MD.
Meet our experts at booth #30 on the 22-24th January in Washington, DC.
Learn about M&A related Regulatory activities (Pre – and Post-Merger) and gain expert insights for successful execution of these activities
As foreseen in our last update, the future location of the European Medicines Agency (EMA) has now been announced.
The appointment of Laura Monkiene enhances the Regulatory Outsourcing Team and expands regulatory footprint, strengthening presence in the CIS region
The merger with TRAC Services will further consolidate our industry-leading team in the UK, strengthening our core services and bringing regional expansion in regulatory affairs
Last month, the European Medicines Agency (EMA) published its Brexit Preparedness Business Continuity Plan and has announced this week that it is getting ready for its relocation decision.
Temporary Authorization for Use (ATU) : How to get started?
The appointment of Adrian Pencak demonstrates PharmaLex’s commitment to strengthening its global sales organization
The partnership will enable the automation of summary documents using Artificial Intelligence based software
The new collaboration will use innovative AI technology to support PharmaLex’s pharmacovigilance solutions
Outsourcing can help fulfil a specific gap in expertise or manage an entire portfolio.
We are now able to offer our clients a real tax benefit.
Dr. Jones received an Honorary Lifetime Fellowship at the 33rd International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE) on August 29, 2017 in Montreal, Canada
Biosimilar development: How to get started? Implementing the best strategies to increase efficiency.
The merger with McGee Pharma International brings additional resource and significant experience in quality management and compliance services
Access our on-demand Webinar and learn how to submit INDs in eCTD format
The appointment of Dr. Adam King enhances the UK management team as well as providing a regulatory focus on M&A activities for the Group
During our office opening event in Munich on the 17th of May 2017, we took the opportunity to discuss the possible implications of Brexit in the life science industry with our guest speaker, David Jefferys.
Access our on-demand Webinar and find out how to run successful FDA meetings
New advanced therapy designed to repair cartilage defects in the knee will become available across the EU
The appointment of Zeb Younes demonstrates the Group’s commitment to providing greater access to specialist expertise
The merger with Nordic Health Economics AB will guide clients through the Nordic reimbursement landscape
In this latest update on Brexit from PharmaLex, we report on the release of the latest, specific Q&As in relation to pharmaceutical regulation and provide our comments.
Dr. David Jefferies (SVP at Eisai and chair at the EFPIA) had joined us to speak on the topic “The Licensing of Medicines – Consequences of UK “Brexit Vote”
We have previously reported on how the European Medicines Agency (EMA) has issued statements about the possible implications of Brexit. CMDh has now also issued a similar statement aimed specifically at MAHs
The merger with the compliance and quality specialist company, Complya Consulting Group, supports a key strategic goal and builds on PharmaLex’s recent US-based acquisitions
As you will be aware, Article 50 was triggered on the 29th March 2017. Following this, negotiations will be commencing on the UK’s withdrawal from the EU.
The merger reinforces PharmaLex’s intentions to build its US business following its recent acquisition of Safis Solutions
The merger demonstrates PharmaLex’s commitment to the US market and complements its existing EU medical device expertise
The Bulgarian office provides PharmaLex with cost-effective access to highly qualified EU expertise
The addition of this service allows the Group to drive its specialist drug safety expertise within the US
The appointment of two key experts demonstrates the Group’s commitment to providing a consistently high level of service
The merger provides PharmaLex with a new specialized service line, further strengthening their service portfolio
The new office is headed by Ms. Sophie Guillaume, General Manager PharmaLex France, and Mr. Patrick Larcier, Senior Director Drug Development and Vigilance.
Connecticut‐based Pharmaceutical Regulatory Affairs service provider, PharmaLex US, announced today that it has entered into a cooperative agreement with H. L. Dorfman Pharmaceutical Consulting, LLC.
The office opening in Paris, France, gives PharmaLex the opportunity to extend its local reach in one of the key worldwide markets.
The merger further expands PharmaLex’s Nordic presence, providing greater capacities and capabilities in regulatory affairs and pharmacovigilance
The merger will further strengthen PharmaLex’s internationalization objective, allowing for greater global reach and local presence.
PharmaLex Group announces the opening of an affiliate office in Basel to further strengthen and support the growing local and international customer base in Switzerland. With this foundation PharmaLex reaches another key milestone to drive internationalization aiming for “Global Reach with Local Presence
YES Pharma Services and PharmaLex, two renowned service providers in Drug Development, Regulatory Affairs, and Pharmacovigilance have today announced their merger pending a positive decision from the German Federal Cartel Office (Bundeskartellamt).