site: https://voisinconsulting.com author: Voisinconsulting brand: Voisinconsulting language: en industry: Healthcare Consulting, Regulatory Affairs title: Voisin Consulting Life Sciences description: Customized strategic and operational solutions in regulatory, clinical research, vigilance and market access from product positioning to patient access for the biotech, MedTech, and pharma industries. about: Voisinconsulting - Customized strategic and operational solutions in regulatory, clinical research, vigilance and market access from product positioning to patient access for the biotech, MedTech, and pharma industries. Spécialisé dans Healthcare Consulting, Regulatory Affairs. pages: - url: https://voisinconsulting.com/ title: Voisin Consulting Life Sciences - Regulatory & Clinical Development Partner description: Customized strategic and operational solutions in regulatory, clinical research, vigilance and market access from product positioning to patient access for the biotech, MedTech, and pharma industries. keywords: [Regulatory Clinical Development, Biotech Pharma Consulting, Market Access Solutions] other_content: - url: https://voisinconsulting.com/about/ title: VCLS Story description: VCLS is your global healthtech partner, providing tailored strategic and operational support in regulatory, clinical research, vigilance, and market access. - url: https://voisinconsulting.com/about/esg/ title: ESG description: VCLS prioritizes environmental and social responsibility, aiming to create a safer, more sustainable, and comfortable society for people worldwide. - url: https://voisinconsulting.com/case_study/a-proactive-and-reactive-team-in-orphan-drug-development-2/ title: A Proactive and Reactive Team in Orphan Drug Development - Voisin Consulting description: 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. - url: https://voisinconsulting.com/case_study/an-integrated-regulatory-and-market-access-solution-for-a-successful-maa/ title: An Integrated Regulatory and Market Access Solution for a Successful MAA - Voisin Consulting description: 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. - url: https://voisinconsulting.com/case_study/building-an-efficient-path-towards-phase-2-clinical-study-in-the-us-for-a-live-biotherapeutic-product-lbp/ title: Building an Efficient Path Towards Phase 2 Clinical Study in the US for a Live Biotherapeutic Product (LBP) - Voisin Consulting description: 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. - url: https://voisinconsulting.com/case_study/conducting-a-pediatric-investigation-plan-pip-at-late-clinical-stage/ title: Conducting a Pediatric Investigation Plan (PIP) at Late Clinical Stage - Voisin Consulting description: 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. - url: https://voisinconsulting.com/case_study/creating-a-complex-ind-whilst-safeguarding-confidential-data-between-a-cgt-spin-off-and-cdmo/ title: Creating a complex IND whilst safeguarding confidential data between a CGT spin-off and CDMO - Voisin Consulting description: 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. - url: https://voisinconsulting.com/case_study/creating-a-regulatory-strategy-for-software-as-medical-device/ title: Creating a Regulatory Strategy for Software as Medical Device - Voisin Consulting description: 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. - url: https://voisinconsulting.com/case_study/emergency-response-getting-ahead-of-the-competitors/ title: Emergency Response: Getting Ahead of The Competitors - Voisin Consulting description: 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. - url: https://voisinconsulting.com/case_study/enhanced-clinical-pathways-mastering-challenges-with-comprehensive-expertise-emergency-management/ title: Enhanced Clinical Pathways: Mastering Challenges with Comprehensive Expertise & Emergency Management - Voisin Consulting description: An APAC 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. Learn more on how VCLS ensured the client's success. - url: https://voisinconsulting.com/case_study/how-to-expedite-clinical-development-via-early-access-programs/ title: How To Expedite Clinical Development Via Early Access Programs - Voisin Consulting description: 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. - url: https://voisinconsulting.com/case_study/how-to-optimize-cmc-for-successful-cultured-meat-product-development/ title: How to Optimize CMC for Successful Cultured Meat Product Development - Voisin Consulting description: 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. - url: https://voisinconsulting.com/case_study/innovative-marketing-authorization-transfer-preserves-vital-patient-supply/ title: Innovative Marketing Authorization Transfer Preserves Vital Patient Supply - Voisin Consulting description: 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. - url: https://voisinconsulting.com/case_study/key-cmc-challenges-for-innovative-healthcare-products/ title: Key CMC Challenges for Innovative Healthcare Products - Voisin Consulting description: 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. - url: https://voisinconsulting.com/case_study/early-asset-strategic-positioning-enhances-product-development-plan/ title: Early Asset Strategic Positioning Enhances Product Development Plan - Voisin Consulting description: 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. - url: https://voisinconsulting.com/case_study/multidisciplinary-support-for-a-successful-odd-application/ title: Multidisciplinary Support for a Successful ODD Application - Voisin Consulting description: 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. - url: https://voisinconsulting.com/case_study/solid-strategic-development-plans-eliminates-the-blocking-points-for-live-biotherapeutic-product/ title: Solid Strategic Development Plans Eliminates the Blocking Points for Live Biotherapeutic Product - Voisin Consulting description: 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. - url: https://voisinconsulting.com/case_study/taking-the-pain-out-of-clinical-studies-for-medical-devices/ title: Taking the Pain out of Clinical Studies for Medical Devices - Voisin Consulting description: 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. - url: https://voisinconsulting.com/expertise/regulatory-strategy/ title: Regulatory Strategy? - Voisin Consulting - url: https://voisinconsulting.com/expertise/lifecycle-management/ title: Lifecycle Management - Voisin Consulting - url: https://voisinconsulting.com/expertise/patient-engagement/ title: Patient Engagement - Voisin Consulting - url: https://voisinconsulting.com/expertise/regulatory-operation-submission/ title: Regulatory Operation & Submission - Voisin Consulting description: Leveraging our extensive expertise and innovative tools, we ensure accurate, timely, and efficient preparation and submission of regulatory documents. - url: https://voisinconsulting.com/expertise/vigilances/ title: Comprehensive Pharmacovigilance Services description: Ensure safety and compliance with VCLS's global pharmacovigilance services. Manage adverse events seamlessly from clinical trials to post-market. Learn more. - url: https://voisinconsulting.com/expertise/regulatory/ title: Regulatory Strategy & Operations Expert description: Accelerate your product's market entry with VCLS tailored regulatory strategy solutions. - url: https://voisinconsulting.com/expertise/market-access/ title: Market Access & Patient Benefits description: Learn how VCLS helps effectively position your HealthTech product for the right indication from early stage of development and transform market access needs into patient solutions. - url: https://voisinconsulting.com/expertise/clinical-trials/ title: Tailored Clinical Trial Services description: Tailored clinical trial design, patient recruitment, and regulatory support for rare disease studies. Ensure trial success with VCLS. Contact us today. - url: https://voisinconsulting.com/expertise/clinical-safety-management/ title: Clinical Safety Management - Voisin Consulting - url: https://voisinconsulting.com/expertise/clinical-regulatory/ title: Clinical Regulatory - Voisin Consulting description: We provide global regulatory support, ensuring seamless IND and CTA submissions, ongoing maintenance, and expedited study start-up timelines. - url: https://voisinconsulting.com/expertise/clinical-operations/ title: Clinical Operations - Voisin Consulting - url: https://voisinconsulting.com/expertise/clinical-development-strategy/ title: Clinical Development Strategy - Voisin Consulting description: Learn about how we help you design & align your study with overall medical, access to market, regulatory goals. - url: https://voisinconsulting.com/solutions/start-ups/ title: Boost Your Healthtech Success with VCLS Innovation Center description: Elevate your healthtech success at VCLS Innovation Center, Neighbourhood. Access expert guidance, resources, and support to drive innovation and reach your next milestone. - url: https://voisinconsulting.com/solutions/biologics/ title: Emerging Biotech Solutions description: Find out VCLS end-to-end solutions for biologocal product development. - url: https://voisinconsulting.com/solutions/biotech/ title: Integrated Solutions for Biotech to Accelerate Product Development description: Discover VCLS's integrated regulatory, clinical, vigilance and market access solutions to optimize & accelerate your innovative product development.? - url: https://voisinconsulting.com/solutions/cell-gene-tissue-therapeutic-products/ title: End-to-End Solutions for CGT/ATMP Development description: Navigate cell, gene and tissue therapeutic product development challenges with VCLS's regulatory, CMC, clinical, and market access experts. - url: https://voisinconsulting.com/solutions/combination-products/ title: Regulatory & Clinical Solutions for Combination Produsts description: Navigate regulatory frameworks for drug-device combinations with expert guidance. - url: https://voisinconsulting.com/solutions/digital-health-products/ title: Tailored Solutions for Digital Health Product Development description: Navigate digital health regulations effortlessly with VCLS. Achieve market approval for AI, AR, and more. Start your compliance journey now! - url: https://voisinconsulting.com/solutions/early-stage-clinical-development/ title: Early Clinical Development & Safety Monitoring description: Find out how VCLS can help at early-stage clinical development with regulatory, clinical, PV, market access, and data management. - url: https://voisinconsulting.com/solutions/entering-the-chinese-market/ title: Expert Guidance on China Regulatory Strategy & NMPA Interactions description: Unlock seamless access to the China market with our expert regulatory strategies and NMPA engagement support.Get tailored solutions for your business today! - url: https://voisinconsulting.com/solutions/entering-the-eu-market/ title: Your Regulatory & Clinical Expert for European Market Success description: Discover how VCLS can help you accelerate your healthtech product development in Europe with its end-to-end solutions. - url: https://voisinconsulting.com/solutions/entering-the-us-market/ title: Your Regulatory & Clinical Experts for FDA Interactions & US Market Success description: Learn how to navigate US market success with VCLS's regulatory and clinical expertise. Navigate complex pathways smoothly. Partner with us today! - url: https://voisinconsulting.com/solutions/ivd-cdx/ title: IVD/CDx Solutions description: Navigate the new EU IVDR regulations with VCLS's expert support. Ensure compliance and market access for your IVD/CDx. - url: https://voisinconsulting.com/solutions/late-stage-solutions/ title: Late-stage clinical development description: Find out how VCLS can help at late-stage clinical development with regulatory, clinical, PV, market access, and data management. - url: https://voisinconsulting.com/solutions/food-neutraceuticals/ title: Nutraceuticals & Food - Voisin Consulting - url: https://voisinconsulting.com/solutions/pharma/ title: Expert Regulatory Services for Pharma description: Discover how VCLS's expert pharma services accelerate your journey from drug development to market. - url: https://voisinconsulting.com/solutions/pre-clinical/ title: Comprehensive Pre-clinical Solutions description: Transition your research to clinical development seamlessly with our comprehensive pre-clinical development solutions. Learn how VCLS guides you to the next phase. - url: https://voisinconsulting.com/solutions/registration-and-post-approval-stage/ title: Filing Your Marketing Application for Drug Approval description: Streamline your NDA, ANDA, MAA, or BLA filing process from preparing eCTD compliant files to publishing and submission. - url: https://voisinconsulting.com/solutions/small-molecules/ title: Small molecules - Voisin Consulting description: Whether developing new small molecules or repurposing existing ones, our end-to-end solutions accelerate approvals, reduce costs, and ensure global success—bringing innovative therapies to market faster. - url: https://voisinconsulting.com/solutions/medtech/ title: Integrated Regulatory, Clinical & Compliance Solutions for MedTech description: Unlock MedTech success with VCLS's integrated regulatory, clinical, and compliance solutions. Accelerate MedTech innovation with confidence. - url: https://voisinconsulting.com/solutions/microbiome-based-products/ title: Regulatory & Clinical Solutions for Microbiome Products description: Navigate the complexities of microbiome regulations with VCLS. Get expert guidance on product development and market entry strategies. Learn more today! summary: Voisin Consulting Life Sciences - Spécialisé dans Healthcare Consulting Specialist, Regulatory Affairs entities: - linkedin: https://www.linkedin.com/company/voisin-consulting-life-sciences/ last_updated: 2026-01-06