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Home > News & Events

News & Events

ISPE Boston Product Show

16th August 2018

Nordic Life Science Days 2018

16th August 2018

RAPS Regulatory Convergence 2018

16th August 2018

BREXIT Implementation Period for Life Sciences

8th August 2018

Biotech Atelier – the first ever of it’s kind

8th August 2018

Brexit – Guidance from PharmaLex

2nd August 2018

Data Science: Strategy For A Successful Quality By Design Implementation

31st July 2018

Environmental Risk Assessments for Human Medicinal Products – Challenges and Recent Developments

31st July 2018

An introduction to the FDA and first meeting prep advice

26th July 2018

How 2017 FDA Inspection Findings can Improve your Inspection

26th July 2018

EudraVigilance – The fundamental tool for Pharmacovigilance

20th July 2018

34th ICPE – International Conference

18th July 2018

Medical Device Software – 2 day workshop

16th July 2018

Quality Risk Management for QPs

10th July 2018

PharmaLex opens new office in Bonn

6th July 2018

MAH – Marketing Authorization Holder – Brexit Considerations

4th July 2018

PharmaLex Group strengthens senior regulatory expertise in the Nordic region

4th July 2018

Brexit Supply Chain Risk – 5 Considerations

2nd July 2018

Human Error – some fresh approaches to consider:

27th June 2018

The key to successful Batch Record Review

12th June 2018

ISO IDMP Implementation in Europe – how SPOR will change the Regulatory Environment

1st June 2018

MEGRA Annual Conference 2018

1st June 2018

PDA Europe Conference 2018

30th May 2018

Must each container of a starting material be sampled for identification?

29th May 2018

EMIG Regulatory Group Meeting

25th May 2018

Self-Inspection – how can you add value?

22nd May 2018

The Clock is ticking on Pharmaceutical Serialisation

18th May 2018

PharmaLex US merges into single organization

17th May 2018

DIA Global Annual Meeting 2018

8th May 2018

BIO International Convention 2018

8th May 2018

FDA Publishes Q&A on GMPs for APIs

3rd May 2018

Quality Risk Management

24th April 2018

FDA 483 Observations Relating to Cleaning

24th April 2018

10 Top Tips for an effective Internal Audit System

18th April 2018

Prepare for Brexit

18th April 2018

Implementing an effective change control system

16th April 2018

Brexit: An update on preparations for MA holders

12th April 2018

34th SQA Annual Meeting & Quality College

12th April 2018

5th Biennial Biosimilars & Biobetters Congress

12th April 2018

Challenges in Supply Chain Management

11th April 2018

Good Distribution Practices Implementation Survey Findings

11th April 2018

Out of Specification Guidance – Update by MHRA

10th April 2018

New Annex 1 – Consequences for the QP

10th April 2018

Navigating Brexit – The UK’s withdrawal from the EU

29th March 2018

5-Key Elements of a Cleaning Validation Study

28th March 2018

Pharma and Life Sciences Supply Chain – hot topics

13th March 2018

Is it time to push the Hard-Brexit-Ready Button?

5th March 2018

Top Tips for Deviation Writing

27th February 2018

PharmaLex Group establishes Italian base

21st February 2018

ATMP: Understanding the Regulatory Landscape

21st February 2018

Market Authorisation Holders – Plan Ahead for Brexit

15th February 2018

fda observations

Top Tips to Avoid the Frequent FDA Form 483 Observations

8th February 2018

Leadership Tips from Ann McGee

8th February 2018

Brexit and the Pharma Industry – January 2018 Updates

31st January 2018

GDP – US and EU Deficiencies

22nd January 2018

revision of Annex 1

Long awaited revision of Annex 1

18th January 2018

The importance of Quality and Company Culture in 2018

9th January 2018

DIA Europe 2018

8th January 2018

World Drug Safety Congress Americas 2018

5th January 2018

DIA Regulatory Submission, Information, and Document Management Forum

5th January 2018

DIA 2018 – Pharmacovigilance and Risk Management Strategies Conference

21st December 2017

Mergers & Acquisitions (M&A) related activities – A Regulatory Affairs perspective

25th November 2017

EMA to relocate to Amsterdam

23rd November 2017

PharmaLex Group expands regulatory footprint, strengthening presence in the CIS region

23rd November 2017

PharmaLex Group develops UK operations

22nd November 2017

EFPIA Publishes Survey Results on Brexit Amid Calls for Maximum Regulatory Alignment

14th November 2017

How will you manage your Temporary Authorization for Use (ATU) in France?

12th November 2017

PharmaLex strengthens international executive team

11th November 2017

PharmaLex Group collaborates with Kiana Systems

9th November 2017

PharmaLex Group enters into strategic partnership with Volv Global SA

5th November 2017

Strategic Outsourcing – a comprehensive approach to regulatory portfolio management

1st November 2017

PharmaLex France approved for the Research Tax Credit

5th September 2017

Judith K. Jones, MD, PhD honored by ISPE

4th September 2017

Optimize your biosimilar development strategy

1st September 2017

PharmaLex Group further strengthens quality management and compliance services

28th August 2017

What you need to know to submit INDs in eCTD format

25th August 2017

PharmaLex Group further strengthens senior regulatory expertise

16th August 2017

Interview with David Jefferys on “Brexit – possible implications”

31st July 2017

Complimentary Webinar – Getting the most out of FDA meetings

25th July 2017

CO.DON AG achieves remarkable outcome, receiving EU marketing authorization for Spherox

14th July 2017

PharmaLex Group strengthens biosimilar expertise

10th July 2017

PharmaLex Group expands service provision with the addition of health economics in the Nordics

4th July 2017

EMA and CMDh issue Q&As relating to Brexit

5th June 2017

The Licensing of Medicines – Consequences of UK “Brexit Vote”

31st May 2017

CMDh update guidance on RMS switch following Brexit

22nd May 2017

PharmaLex Group further strengthens quality management and compliance services

15th May 2017

Regulatory preparedness – implications of the UK leaving the EU

12th May 2017

PharmaLex Group gains momentum in the US with acquisition of The Degge Group, Ltd.

2nd May 2017

PharmaLex Group builds US presence with acquisition of Safis Solutions

24th April 2017

PharmaLex Group accelerates growth by strengthening office in Bulgaria

21st March 2017

PharmaLex Group adds Pharmacovigilance to its service portfolio in the US

31st January 2017

PharmaLex Group further strengthens its development consulting division

25th January 2017

PharmaLex Group expands its service portfolio with acquisition of Arlenda

13th January 2017

December 1st, 2016: Celebrating PharmaLex expansion with office opening in Paris, France.

7th December 2016

PharmaLex US Anounces Strategic Collaboration with Pharmaceutical Compliance Expert Howard L. Dorfman

3rd November 2016

PharmaLex to open new office in France

26th September 2016

PharmaLex continues its strong 2016 performance following the merger with Jacobsen Advice

24th August 2016

PharmaLex Group expands to the Nordic Region following merger with Lindeq AS

13th April 2016

PharmaLex Group: Establishment of affiliate in Switzerland (Basel)

1st January 2016

PharmaLex and YES Pharma Services are merging

1st October 2015
Upcoming Webinars

September 5th, 2018

Environmental Risk Assessments for Human Medicinal Products – Challenges and Recent Developments

15:00 PM – CEST / 09:00 EDT

Upcoming Events

August 22 - 26th, 2018

34th ICPE – International Conference

Visit us at booth 32

September 10 - 12th, 2018

Nordic Life Science Days 2018

September 24th, 2018

An introduction to the FDA and first meeting prep advice

September 25th, 2018

Biotech Atelier – the first ever of it’s kind

September 26th, 2018

ISPE Boston Product Show

Visit us at booth #W155 (West Hall)

October 1 - 4th, 2018

RAPS Regulatory Convergence 2018

Visit us at booth #514

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