Voisin Consulting Life Sciences

Developed by SoXtra, this is the first treatment acting as a BKCa channel activator offering a personalized approach for patients with Fragile X Syndrome, a major cause of monogenic autism and intellectual disability.

Developed by Vanarix, this patented technology solves dedifferentiation and loss of function in chondrocytes during expansion, enabling cells to regain full capacity to synthesize a hyaline matrix.

A proprietary technology developed by TreeFrog Therapeutics for the mass-production of stem cells, dramatically reducing treatment costs while introducing a new quality standard for cell therapies.

First-in-class biotherapies developed by ILONOV to prevent and cure diabetes based on a muscle-secreted hormone that protects pancreatic islets in islet transplant and Type 2 Diabetes.

A weeklong immersion experience allowing mentored startups to integrate the Boston innovation ecosystem, better understand FDA requirements, and how to access the US market.

A revolutionary treatment developed by Neurophoenix for chronic and acute optic neuropathies such as glaucoma or retina ischemia, based on a molecule derived from a virus that reactivates survival mechanisms of injured neurons.

Tailored mentoring and advisory services including face-to-face meetings, events with healthtech entrepreneurs and VCs, community exchange, and access to office facilities.

Guidance through development of digital health technology, SaMD, IVD/companion diagnostics, delivery systems, from product classification under MDR to clinical plan and post-market surveillance.

Consulting service for Investigational New Drug (IND) application preparation and submission to FDA.

Global vigilance solutions from pre-market safety to post-market surveillance, including case management, safety regulatory, signal detection & risk management, safety writing, and post-marketing & QPPV services.

Consulting service to define post-approval strategies including lifecycle management and regulatory compliance.

Consulting service for New Drug Application (NDA) and Biologic License Application (BLA) planning to support regulatory approval.

Consulting service to prepare Module 3 (CMC) of the CTD for regulatory submissions to FDA and other health authorities.

Consulting service for early FDA interactions including INTERACT and Pre-IND meeting preparation and engagement to support regulatory strategy and compliance.

A combination technology under clinical evaluation that treats disseminated and inaccessible brain cancer cells during surgery, improving survival outcomes.

Consulting service for developing chemistry, manufacturing, and controls (CMC) strategy including raw material sourcing and initial process development.

Author, prepare, and submit appropriate clinical trial applications (CTAs, INDs) and write and review responses to information requests from authorities and Drug Master Files (DMFs).

Consulting service to apply for and provide guidance on accelerated approval pathways with the FDA.

Developed by BIOPHTA to reduce treatment burden and improve adherence to prescription eye drops, addressing the #1 unmet medical need in ophthalmology.

Case management and Adverse Event Reporting (AER), periodic and aggregate safety reporting, risk management and labeling updates, pharmacovigilance system oversight, and regulatory inspections and compliance.

A series of three, two-hour, face-to-face mentoring sessions to discuss and refine unique projects, developing target product profiles and regulatory roadmaps.

Consulting service for early engagement with payers to support market access and reimbursement strategy.

Consulting service to establish post-marketing safety systems to monitor product safety and ensure regulatory compliance.

Consulting service to assess eligibility for FDA expedited programs and Orphan Drug Designation to accelerate development and approval processes.

Marketing application submission and management towards approval, including guidance in comparability in case of production transfer and strategic planning for post-approval activities.

Consulting service to design a nonclinical development plan tailored to regulatory requirements and product needs.

A SaaS tech-enabled solution offering a set of proprietary clinical trial tools such as CDMS, CTMS, ePRO, eTMF to facilitate the efficiency, accuracy, and safety of clinical trials.

Consulting service for design and implementation of pivotal clinical studies to support regulatory submissions.

A customized solution for regulatory strategy and filing, NMPA interaction, and other regulatory consulting services tailored to the Chinese pharmaceutical market.

Consulting service to generate Real-World Evidence (RWE) to support long-term market positioning and value demonstration of biopharmaceutical products.

Consulting service to develop value dossiers, core economic models, and pricing strategies to support market access and reimbursement.

Developed by Diotheris, these microbes prevent bacterial infections and reduce the spread of antibiotic resistance, targeting Staphylococcus aureus nasal carriage and other applications.

Consulting service for submission and review of product labeling to ensure regulatory compliance and market readiness.

Consulting service to attend post-approval FDA meetings and address Post-Marketing Requirements (PMRs) and Post-Marketing Commitments (PMCs).

Submission capabilities via FDA Electronic Submissions Gateway (ESG), EMA Gateway, PSUR Repository, CESP, and full e-publishing submission management in internal or external environments.

Consulting service to develop strategy for manufacturing process scale-up to support clinical and commercial supply.

Consulting service for development and validation of analytical methods to support clinical supply chain and product quality.

Consulting service to design and implement safety systems for clinical trials ensuring patient safety and regulatory compliance.

Consulting service to design and implement comprehensive Risk Management Plans for regulatory compliance and product safety.

A focused two-hour plenary session by an expert VCLS consultant, followed by customized workshops and networking events for institutions and partner organizations.