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
    • Our Milestones
    • Corporate Social Responsibility
    • 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 > Blog > Page 2

Blog

When is a Standard Actually a Standard?

When is a Standard Actually a Standard?

26th July 2021

The bio pharmacy: market authorisations for protein-based medicines

The bio pharmacy: market authorisations for protein-based medicines

12th July 2021

Update on Notified Bodies designation under MDR / IVDR

Update on Notified Bodies designation under MDR / IVDR

2nd July 2021

MR Compatibility and Materials Science

MR Compatibility and Materials Science

1st July 2021

Australia’s TGA releases updated Essential Principles Checklist

Australia’s TGA releases updated Essential Principles Checklist

27th May 2021

FDA & “Certain Devices” with Intact Skin Contact – Draft Guidance Assessment

FDA & “Certain Devices” with Intact Skin Contact – Draft Guidance Assessment

25th May 2021

It’s all about Access!

It’s all about Access!

18th May 2021

Alternative Pathways for Medical Device Market Authorisation

Alternative Pathways for Medical Device Market Authorisation

29th April 2021

China Medical Device Regulations – Major Updates

China Medical Device Regulations – Major Updates

8th April 2021

European Medical Devices Regulation (EU MDR) Implementation date is just around the corner

European Medical Devices Regulation (EU MDR) Implementation date is just around the corner

30th March 2021

Technical File Differences Between Medical Devices and IVD Medical Devices

Technical File Differences Between Medical Devices and IVD Medical Devices

26th March 2021

Taiwan FDA Unique Device Identifier (UDI) Draft Regulation

Taiwan FDA Unique Device Identifier (UDI) Draft Regulation

8th March 2021
123456
prevnext
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
  • Statistics and Data Science
RECENT TWEETS
PharmaLexGLOBALPharmaLex@PharmaLexGLOBAL·
14 Jan

January 14th marks the celebration of the #OrthodoxNewYear in certain countries, according to the Julian calendar.

PharmaLex is wishing everyone who celebrated the Old New Year a peaceful and blessed holiday!

COVID-19 NEWSLETTER SIGN UP

SIGN UP NOW

WHAT OUR CLIENTS SAY

  • Provided honest feedback and collaborative working solutions to obstacles

    South Korea based medium sized company
    Manager
PharmaLex
©2022 PharmaLex GmbH. All rights reserved.

ISO9001:2015 LogoEnergie Audit LogoSGS Logo

    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.

    Click here to view our Privacy Policy.

    #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