TwitterLinkedin

Contact Us

  • Biopharma Excellence
  • News & Events
    • Industry News Articles
    • Press Releases
    • Webinars
    • Events
    • Blog
    • Podcasts
  • Resource Library
    • Thought Leadership
    • Fact Flyers
    • Case Studies
    • White Papers
    • Webinars
    • Infographics
    • Video & Animation
  • Careers
    • Life at PharmaLex
    • Current Opportunities
  • Training
Top Bar
Search
PharmaLex Logo
MENUMENU
  • PharmaLex Logo
  • PharmaLex Logo
  • About UsAbout Us
    • About Us
    • Management Team
    • Corporate Social Responsibility
    • Sustainability
    • What Our Clients Say About Us
  • Our Services
    • Discovery / Non-clinical

          • Go to Discovery / Non-clinical section >>

          • Strategy and Consulting

            • Integrated Product Development
            • Market Access
            • Scientific Advice
            • Statistics and Data Sciences
            • Toxicology Services
    • Clinical Development

          • Go to Clinical Development section >>

          • Strategy and Consulting

            • Clinical Program Development
            • Scientific Advice
            • Statistics and Data Sciences

          • Regulatory Affairs

            • Clinical Trial Applications
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Regulatory Operations

          • Pharmacovigilance

            • Clinical Trial Safety Support
            • Pharmacovigilance Consulting

          • Quality

            • GxP Services
            • Interim / Contract QA
            • Quality Management Systems
            • Tech Transfer / Scale-up
    • Authorization / Approval

          • Go to Authorization / Approval section >>

          • Strategy and Consulting

            • Market Access

          • Regulatory Affairs

            • CMC Services
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Marketing and Labeling Activities
            • Regulatory Operations
            • Scientific, Regulatory and Technical Writing
            • Statistics and Data Sciences

          • Pharmacovigilance

            • EU QPPV / National QPPV
            • Pharmacovigilance Consulting

          • Quality

            • Commercialization Readiness
            • Commissioning, Qualification, and Validation (CQV)
            • GxP Services
            • Interim / Contract QA
            • PAI Readiness
    • Post-approval / Maintenance

          • Go to Post-approval / Maintenance section >>

          • Strategy and Consulting

            • Market Access

          • Regulatory Affairs

            • CMC Services
            • Global End-to-End Outsourcing
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Marketing and Labeling Activities
            • Mergers and Acquisitions (M&A) Transfers
            • Regulatory Operations
            • Toxicology Services

          • Pharmacovigilance

            • EU QPPV / National QPPV
            • ICSR (Individual Safety Case Report) Management
            • Literature Monitoring & Screening
            • Pharmacovigilance Quality & Compliance
            • Signal Management

          • Quality

            • Commissioning, Qualification, and Validation (CQV)
            • GxP Services
            • Interim / Contract QA
            • Quality Management Systems

          • Medical Affairs

            • Healthcare Compliance and Medical Approval
    • Program Management

          • Go to Program Management section >>

          • Program Management

            • Global End-to-End Outsourcing
            • Global Procedure Management
            • Integrated Product Development
            • Mergers and Acquisitions (M&A) Transfers
    • Featured Expertise

          • Industry Expertise

            • Biopharmaceuticals
            • MedTech Services

          • Service Expertise

            • ATMP / Cell and Gene Therapy
            • COVID-19 Support
            • GxP Services
            • Market Access
            • Pharmacovigilance Consulting
            • Post-Brexit Regulatory Support
            • Statistics and Data Sciences
            • SMARTPHLEX - technology-enabled services
  • Global ReachGlobal Reach
  • Contact usContact us
  • News & Events
    • Industry News Articles
    • Press Releases
    • Webinars
    • Events
    • Blog
    • Podcasts
  • Resource Library
    • Thought Leadership
    • Fact Flyers
    • Case Studies
    • White Papers
    • Webinars
    • Infographics
    • Video & Animation
  • Careers
    • Life at PharmaLex
    • Career Opportunities
  • Training
Home > News & Events > Industry News Articles

Category Archives: Industry News Articles

Jane Lyons: ‘Sweep the sheds: never be too big to do the small things that need to be done’

Jane Lyons: ‘Sweep the sheds: never be too big to do the small things that need to be done’

20th September 2022

L’importance du “Bénéfice significatif” dans la désignation de médicament orphelin

L’importance du “Bénéfice significatif” dans la désignation de médicament orphelin

6th September 2022

Preparing for Success – How to have a positive FDA Inspection

Preparing for Success – How to have a positive FDA Inspection

2nd September 2022

The final revision to Annex 1 “Manufacture of Sterile Medicinal Products”

The final revision to Annex 1 “Manufacture of Sterile Medicinal Products”

26th August 2022

Why collaboration and an Integrated Product Development program are key to successful drug development

Why collaboration and an Integrated Product Development program are key to successful drug development

14th June 2022

Key Takeaways from the PDA Europe Annex 1 Workshop

Key Takeaways from the PDA Europe Annex 1 Workshop

7th June 2022

Addressing Limitations of Sterility Testing

Addressing Limitations of Sterility Testing

9th May 2022

Are virtual audits sustainable post-pandemic?

Are virtual audits sustainable post-pandemic?

6th May 2022

Orphan Drug Designation: Securing the Significant Benefits

Orphan Drug Designation: Securing the Significant Benefits

28th March 2022

Virtual Audits: To be, or not to be, that is the question

Virtual Audits: To be, or not to be, that is the question

26th January 2022

Quality Risk Management ICH Q9 – Revision published for public comments

Quality Risk Management ICH Q9 – Revision published for public comments

5th January 2022

Points de vigilance vis-à-vis de la communication institutionnelle en France

Points de vigilance vis-à-vis de la communication institutionnelle en France

23rd November 2021
12345…
6789101112131415161718
19
prevnext
Upcoming Webinars

November 10th, 2022

Meeting your requirements for the IVDR Technical Files

03:00 PM CET

Upcoming Events

October 13th, 2022

OMICS DATA SCIENCE IN DRUG DISCOVERY AND DEVELOPMENT

October 17 - 18th, 2022

TOPRA Annual Symposium

Visit us at booth 1

November 6 - 9th, 2022

ISPOR Europe 2022

Visit us at booth 108

Categories
  • All News
  • Webinars
  • Events
Archive
Biopharma Excellence Website Image

PharmaLex Brings You Biopharma Excellence

Biopharma Excellence is a fusion of three scientific powerhouses, PharmaLex, ERA Consulting and Biopharma Excellence – all under the PharmaLex brand. This global team of scientific, regulatory and commercial professionals provide strategic product development and proactive regulatory services to developers of biopharmaceuticals, cell and gene therapies, monoclonal antibodies (MABs), vaccines and biosimilars.

Visit Website
USEFUL LINKS
  • Home
  • Contact us
  • Imprint
  • Data Protection
  • Terms and Conditions
RECENT TWEETS
pharmalexglobal PharmaLex @pharmalexglobal ·
11h

Did you know PharmaLex does #podcasts?

Talks podcast is a place for discussion on important topics within the Pharmaceutical, biotech and medical device industry.

Listen here: https://lnkd.in/dAjQfp65

COVID-19 NEWSLETTER SIGN UP

SIGN UP NOW

WHAT OUR CLIENTS SAY

  • Able to explain technical details so non-experts can understand

    US based small / virtual company
    Partner
PharmaLex
©2022 PharmaLex GmbH. All rights reserved.

ISO9001:2015 LogoEnergie Audit LogoSGS Logo

Suspicious Emails

We are aware of a number of suspicious emails about recruitment in circulation purporting to be from PharmaLex. Emails sent by PharmaLex will originate from @pharmalex.com. Should you receive an email and are unsure as to its validity, please report it to contact@pharmalex.com.

Many thanks for your understanding.

The PharmaLex Team

    Please DO NOT send us event/conference information.
    We will not respond and these will be deleted immediately.





    Select your state:

    .
    If you do not wish to receive any communication from us, you may unsubscribe at any time.

    #AskTheExpert #TogetherBEYONDCOVID19





      Select your state:

      .
      You can unsubscribe at any time at data.protection@pharmalex.com

      If you do not wish to receive any communication from us, you can unsubscribe at any time at. Click here to view our Privacy Policy.

      #TogetherBEYONDCOVID19

      We closely monitor developments and updates surrounding the current outbreak of Coronavirus Disease 2019 (COVID-19) from official sources including the World Health Organisation and are following the guidance and direction of the governments and the local authorities. We are taking this situation very seriously and our number one priority is the safety and business continuity for our customers and colleagues. As ever, we will do everything we can to ensure that services are delivered within the required time and the trusted quality PharmaLex is known for