Biopharma Excellence
News & Events
Resource Library
Careers
- Life at PharmaLex
- Current Opportunities
Training

Top Bar

MENUMENU

About UsAbout 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
Resource Library
Careers
- Life at PharmaLex
- Career Opportunities
Training

Home > News & Events > Industry News Articles

Category Archives: Industry News Articles

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

7th June 2022

NLS DAYS 2022

September 28 - May 29th, 2022
Visit us at booth X51

Addressing Limitations of Sterility Testing

9th May 2022

Are virtual audits sustainable post-pandemic?

6th May 2022

Orphan Drug Designation: Securing the Significant Benefits

28th March 2022

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

5th January 2022

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

23rd November 2021

Development and Lifecycle Management of Software as a Medical Device

19th October 2021

How to achieve inspection readiness

18th October 2021

Recent changes in Australia for COVID-19 Rapid Antigen Self-Tests

30th September 2021

1 2 3 4 5 …

6 7 8 9 10 11 12 13 14 15 16 17 18

prev next

Upcoming Webinars

June 16th, 2022

Better information, better decisions for your access strategy – Inmediata powered by SmartPHLEX a new platform

2:30 PM CET

June 28th, 2022

eCTD in Australia: key steps to start a successful submission

08:30 am CET / 4:30 pm AEST

June 28th, 2022

An Introduction to Bayesian adaptive methods in clinical trials

04:00 PM CET

June 30th, 2022

Transforming the drug development process with an integrated strategy

03:00 PM CET

Upcoming Events

June 23rd, 2022

DIA 2022 – Reconnect with Your Life Sciences Community Live in Chicago

Visit us at booth #1515

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

PharmaLex @PharmaLexGLOBAL·

8 Jun

Mark A Lane, PhD latest blog here https://lnkd.in/ejDdywz3 explores Integrated Product Development approaches to accelerate drug development.

To find out more register for our IPD webinar https://lnkd.in/eijUBJM5

#pharmadrugdevelopment
#webinar
#biopharmaceutical

COVID-19 NEWSLETTER SIGN UP

WHAT OUR CLIENTS SAY

During the bid defense we felt that you worked well as team and are very dynamic. Preparation of such a complex dossier really needs to be done in such a way.

Large Pharma, Germany
VP Regulatory Affairs

ISO9001:2015 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:

Please tick this box to agree to our Privacy Policy

Please tick this box if you agree to periodic updates from PharmaLex.
If you do not wish to receive any communication from us, you may unsubscribe at any time.

Please leave this field empty.

#AskTheExpert #TogetherBEYONDCOVID19

Select your state:

Please tick this box to agree to our Privacy Policy

Please tick this box if you agree to periodic updates from PharmaLex.
You can unsubscribe at any time at data.protection@pharmalex.com

Please leave this field empty.

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

Strategy and Consulting

Strategy and Consulting

Regulatory Affairs

Pharmacovigilance

Quality

Strategy and Consulting

Regulatory Affairs

Pharmacovigilance

Quality

Strategy and Consulting

Regulatory Affairs

Pharmacovigilance

Quality

Medical Affairs

Program Management

Industry Expertise

Service Expertise

Category Archives: Industry News Articles

PharmaLex Brings You Biopharma Excellence