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Case Studies

Case_study

May 20 2025

Enhanced Clinical Pathways: Mastering Challenges with Comprehensive Expertise & Emergency Management

Published on: May 20th, 2025 An emerging biotech had developed a gene therapy product for rare diseases. When navigating their IND application process, they faced several critical hurdles with very tight timeline available to address. VCLS stepped in to become a proactive and seamless extension of their team to manage the emergency of addressing unexpected […]

  • Cell & Gene Therapy
  • FDA
  • Orphan & Rare Disease
  • Regulatory strategy
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May 30 2024

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

Published on: May 30th, 2024 An APAC biotech had developed a live biotherapeutic product to target a rare liver disease with a high unmet medical need. Considering the nature of the product, a classical product development path was not appropriate and adapted development strategy had to be elaborated in view of supporting a Clinical trial […]

  • Microbiome
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Feb 02 2024

Creating a complex IND whilst safeguarding confidential data between a CGT spin-off and CDMO

Published on: Feb 2nd, 2024 When submitting and IND for CGT product/therapy, it’s crucial to confirm that the viral vector in use is appropriate, especially when it’s produced by a third-party organization. In this case study, we explore how VCLS supported a US-based company trying to gain IND for its cell and gene therapy. We […]

  • Cell & Gene Therapy
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May 19 2023

How to Optimize CMC for Successful Cultured Meat Product Development

Published on: May 19th, 2023 Cultured meat products are novel in the market, there are no regulatory and CMC guidelines specifically dedicated to them. Therefore, the regulatory and development strategy must be customized on a case-by-case basis. In this case study, we explore how VCLS supported a company trying to gain approval for its cultured […]

  • CMC
  • Regulatory strategy
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Jan 26 2023

Innovative Marketing Authorization Transfer Preserves Vital Patient Supply

Published on: Jan 26th, 2023 The marketing authorization is a key step in the product development pipeline of any healthtech product. It involves the assessment of all collected evidence supporting a healthcare product, before granting approval for marketing and sales. The marketing authorization transfer entails the transfer of the dossier from the current holder to […]

  • Clinical Studies
  • Early Access Programs
  • EMA
  • Orphan & Rare Disease
  • Regulatory strategy
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Jan 19 2023

How To Expedite Clinical Development Via Early Access Programs

Published on: Jan 19th, 2023 If you are developing a drug for a rare disease in the European Union, you may qualify for an Early Access program to expedite your clinical development. There are two key advantages to obtaining this: Accelerated assessment of your market access application. Compassionate use, where patients fulfilling certain criteria, may […]

  • Clinical Studies
  • Early Access Programs
  • EMA
  • Orphan & Rare Disease
  • Regulatory strategy
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Nov 15 2022

A Proactive and Reactive Team in Orphan Drug Development

Published on: Nov 15th, 2022 Are you in need of a proactive and reactive team in orphan drug development? An orphan drug is a designation existing in both the FDA and the EMA regulatory frameworks. It has been created in order to facilitate access to medical support for those patients suffering from rare disease. In […]

  • Orphan & Rare Disease
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Nov 15 2022

Key CMC Challenges for Innovative Healthcare Products

Published on: Nov 15th, 2022 Have you encountered CMC challenges in the development of your innovative healthcare product? CMC includes all activities vital to product approval: product characteristics, manufacturing methods, and product testing – to ensure product safety, efficiency, and standardization. Moreover, innovative products, such as cell therapy, are classified as ATMPs (Advanced Therapy Medicinal […]

  • ATMP
  • CMC
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Sep 08 2022

Early Asset Strategic Positioning Enhances Product Development Plan

Published on: Aug 9th, 2022 A French based research company was looking for a proper guidance on positioning their main asset and estimate the market potential. We worked alongside the Client to identify the first indication, provided analysis of the price potential and helped developing a Value Proposition. This critical information helped to clarify a […]

  • Market Access
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Feb 08 2022

Solid Strategic Development Plans Eliminates the Blocking Points for Live Biotherapeutic Product

Published on: Feb 8th, 2022 A French biotech had developed a live biotherapeutic product to target obesity and metabolic disease but were hindered by blocking points in the product development process. We worked alongside the Client to identify the specific regulatory and scientific gaps in their plan. This critical information helped to form the solid […]

  • Microbiome
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Apr 26 2021

Conducting a Pediatric Investigation Plan (PIP) at Late Clinical Stage

Published on: Apr 26th, 2021 A US based Biotech company was unaware of the EU’s requirement for a Pediatric Investigation Plan (PIP) until their product development was at Phase III. It was understandable as orphan drugs do not require a Pediatric Study Plan (PSP) in the US. The VCLS team were quick to identify the […]

  • Clinical Trials
  • Paediatric
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May 29 2020

Emergency Response: Getting Ahead of The Competitors

Published on: May 29th, 2020 A US based emerging biopharma recognized that one of their anti-viral therapeutics being developed for a different indication might also help in the fight against the Coronavirus, COVID-19. Due to the emergency of the global pandemic they knew they had to react fast to meet the challenge but didn’t have […]

  • Clinical Trials
  • FDA
  • Regulatory strategy
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Apr 09 2020

Taking the Pain out of Clinical Studies for Medical Devices

Published on: Apr 9th, 2020 A French based research company were looking for guidance on developing a medical device to ensure MD safety validation. VCLS became an extension of their team, designing a comprehensive Clinical Study Management program which optimized the timeline to first-in-patient, ensuring full regulatory compliance along the way.

  • Clinical Studies
  • Medical device
  • Medical Devices
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Feb 24 2020

An Integrated Regulatory and Market Access Solution for a Successful MAA

Published on: Feb 24th, 2020 A US-based biotech looked for a trusted regulatory partner to:1) Build and execute an EU regulatory strategy and roadmap in view of obtaining new drug approval in Europe.2) Manage related clinical trial application and clinical safety activities at a global level.

  • Market Access
  • Regulatory strategy
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Feb 24 2020

Multidisciplinary Support for a Successful ODD Application

Published on: Feb 24th, 2020 A US biopharmaceutical client had to withdraw their ODD application during the COMP’s review procedure, due to the lack of substantial clinical data, as anticipated in VCLS’ feasibility assessment. Two years on, the client asked VCLS to provide expertise to identify the gaps in the studies and recommend a new […]

  • Regulatory strategy
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Jan 15 2020

Creating a Regulatory Strategy for Software as Medical Device

Published on: Jan 15th, 2020 A mobile diabetes software app for patients with diabetes to assist them in the management of their disease by monitoring blood glucose levels, activity, food intake and insulin. Client approached VCLS for strategic and regulatory assistance for Medical Device Software development and certification (CE) mark for the EU market.

  • Medical device