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

Human Microbiomes in Health and Disease: Strategic Options for Regulatory Science and Healthcare Pol...

Learn more about the analytical, ethical and regulatory challenges linked with microbiome testing in...

Jan 07 2025
Whitepaper
  • Nonclinical|Regulatory strategy

Regulatory Trends in the Nonclinical Development of Vir...

As it is often the case with innovative technologi...

Jun 08 2023
Whitepaper
  • Clinical Trials

Are Registries the New “Gold Standard” ?

There are multiple definitions associated with a r...

Apr 14 2023
Whitepaper
  • CMC

CMC considerations for US biosimilars development

The US Biologics Price Competition and Innovation ...

Apr 26 2022
Whitepaper
  • Market Access

IVDR Readiness Checklist

In the blog post “IVD Directive to IVD Regulation ...

Sep 30 2021
Whitepaper
  • in silico

Possible Contexts of Use for In Silico trials methodolo...

The term “In Silico Trial” indicates the use of co...

Jun 28 2021
Whitepaper
  • ATMP|Cell &amp
  • Gene Therapy|EMA|Market Access

Advanced therapies in the EU: challenges with HTA and r...

Market access aims to make a health technology not...

Jun 01 2021
Whitepaper

Human Microbiomes in Health and Disease: Strategic...

  • Microbiome

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

Published on: Sept 4, 2020   This article describe...

Sep 04 2020
Whitepaper
  • Clinical Trials

General Data Protection Regulation and Patients Enrolle...

Processing and cross-border flows of personal data...

Aug 17 2020
Whitepaper
  • Clinical Trials

Clinical Trials with GMOs in the EU - From Regulatory t...

Clinical trials (CTs) with investigational medicin...

Jun 23 2020
Whitepaper
  • Clinical Trials|in silico

Verifying and Validating Quantitative Systems Pharmacol...

The added value of in silico models (including qua...

Apr 03 2020
Whitepaper
  • Clinical Trials|Regulatory strategy

A Regulatory Landscape Shift for In Silico Clinical Tri...

Modelling and simulation (M&S) has grown to become...

Jan 24 2020

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