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Discover our expert insights

We like to keep our readers up to date on complex HealthTech development issues, the latest industry trends and updated guidelines to help you to solve a problem or make an informed decision, and learn how VCLS can provide you with tailored solutions to effectively move your product development forward.

Webinar

Mar 14 2025

Ask the Experts: Navigating FDA & EMA CMC Expectations for Cell and Gene Therapy Product Development

Published on: Mar 14th, 2025 During the session, o...

  • Cell & Gene Therapy
  • FDA
    • ...
  • ...
Webinar

Oct 18 2024

How to master both Marketing Authorization and Joint Clinical Assessment successfully?

How to master both Marketing Authorization and Joi...

  • EMA
  • Market Access
    • ...
  • ...
Blog

Nov 20 2024

The SoHO Regulation: A Step Forward in European Health and Safety

EU has recently introduced a new regulation for su...

  • CMC
Webinar

Feb 20 2024

Demystifying the US IND process for initiation of clinical trials

Published on: Feb 20th, 2024   Submitting an Inves...

  • Regulatory strategy
  • FDA
Blog

Jun 17 2024

De-risk Clinical Trials by Starting with Patient Insights and their Integration

Understanding the perspective and preferences of p...

  • Clinical Trials
Case study

May 30 2024

Building an Efficient Path Towards Phase 2 Clinical Study in the US for a Live Biotherapeutic Product (LBP)

A South Korean biotech had developed a live biothe...

  • Microbiome
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How to Ensure Safety and Efficacy in Medical Device Vigilance via Patient Engagement
Blog
  • Medical device
  • Vigilance
    • ...
  • Patient Engagement

How to Ensure Safety and Efficacy in Medical Device Vigilance via Patient Engagement

Mar 28 2025
Understanding Microbiome Testing Kits: What They Are and How They Are Used
Blog
  • Regulatory strategy
  • Microbiome

Understanding Microbiome Testing Kits: What They Are an...

Microbiome testing is an advanced tool that allows...

Mar 25 2025
Ask the Experts: Navigating FDA & EMA CMC Expectations for Cell and Gene Therapy Product Development
Webinar
  • Cell & Gene Therapy
  • FDA
    • ...
  • EMA
  • CMC

Ask the Experts: Navigating FDA & EMA CMC Expectati...

Published on: Mar 14th, 2025 During the session, o...

Mar 14 2025
The Nordic Opportunity: Turning Real-World Data into a Rare Disease Research Powerhouse
Blog
  • Orphan & Rare Disease
  • Market Access

The Nordic Opportunity: Turning Real-World Data into a ...

Over the past decade, rare diseases have gone from...

Feb 25 2025
Patient Centricity: The Foundation of Modern Healthcare Through Meaningful Engagement 
Blog
  • Regulatory strategy

Patient Centricity: The Foundation of Modern Healthcare...

Feb 21 2025
Key Insights from FDA’s Draft Guidance on FAQs for CGT Quality and Regulatory Interactions
Blog
  • Cell & Gene Therapy
  • FDA
    • ...
  • CMC

Key Insights from FDA’s Draft Guidance on FAQs for CGT:...

The FDA has recently released a draft guidance tit...

Feb 05 2025
Microbiome Testing in Europe: Navigating Analytical, Ethical and Regulatory Challenges
Whitepaper
  • Microbiome

Human Microbiomes in Health and Disease: Strategic Opti...

Learn more about the analytical, ethical and regul...

Jan 07 2025
The SoHO Regulation: A Step Forward in European Health and Safety
Blog

The SoHO Regulation: A Step Forward in European He...

  • CMC

The SoHO Regulation: A Step Forward in European Health ...

EU has recently introduced a new regulation for su...

Nov 20 2024
Webinar
  • EMA
  • Market Access
    • ...
  • Regulatory strategy

How to master both Marketing Authorization and Joint Cl...

How to master both Marketing Authorization and Joi...

Oct 18 2024
New policy opens China biotechnology sector
Blog
  • China
  • Regulatory strategy

New policy opens China biotechnology sector

The recent announced new pilot program in China ex...

Oct 14 2024
Live Biotherapeutic Products (LBPs) for bacterial vaginosis (BV)
Blog
  • Microbiome

Unlocking the potential benefits of Live Biotherapeutic...

Diving into Bacterial Vaginosis (BV) and the role ...

Oct 09 2024
Ask the Experts: How to leverage regulatory interactions to de-risk Microbiome products development in the EU and the US
Webinar
  • Microbiome

Ask the Experts: How to leverage regulatory interaction...

Published on: Aug 8th, 2024 Microbiome science has...

Aug 08 2024

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