Voisin Consulting Life Sciences Voisin Consulting Life Sciences

Overview

Voisin Consulting Life Sciences is a team of experienced healthcare professionals who advise on product development, and helps biomedical companies design regulatory strategies and interacts with regulators. We propose fully customized assistance in response to the very specific needs of biotech and medtech companies striving to move fast from cutting edge research to the market.

Our team guides projects from strategic development planning, through manufacturing & testing, non-clinical development, clinical development, risk management & vigilance, and interactions with regulators and payers.

Number of employees: 70

Main business focus/
Listing by sector:

Industrial Biotechnology

Competitive Advantages

We aim at complementing both your expertise and resources. Our inputs can vary from a few hours on a specific issue, to acting as your externalized product development and regulatory group.
Our technical experts develop customized solutions adapted to each partner company. It is important for us to understand your product and development program, but also your company’s goals and organization.

Technology/IP

Our multidisciplinary team possesses hands-on experience with the development of: drugs & biologics; medical devices; in-vitro diagnostics & companion diagnostics; combination products; cell, gene and tissue therapy products; borderline products, including nutraceuticals & cosmetics.

Corporate Alliances/Partnerships

We work with a network of experts and niche service providers, who add value to our clients' programs.

Clinical Trial Activity

VCLS has extensive experience in the clinical development of a broad range of lifehealthcare products. Our services span from medical strategy to the regulatory and clinical set-up of the clinical programs, either clinical trials or compassionate use programs.

We prepare medically-driven and regulatory-compliant clinical development plans tracing the way from the early clinical stages to the registration. We assist our clients with the organization of steering committees with end-users, CMC, nonclinical and clinical experts. These committees are convened to discuss the prioritization of indications and the study design, in particular the dose selection, the starting dose for first-in-human clinical trials, and the overall protocol design. We also offer our help for the conceptualization and the design of studies outside of steering committees.

Infrastructure

VCLS is an ISO 9001:2008 certified company.

Contact Details

Contact person	Vincent Bergeron
Address	25 Flinders Lane
City/Suburb	Melbourne
State	Victoria
Email	vcmelbourne@voisinconsulting.com
Phone	613 9663 9008
Fax	613 9663 9009
Website	http://www.voisinconsulting.com

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AusMedtech Medical Devices & Diagnostics 2013