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= Voisin Consulting Life Sciences = Voisin Consulting Life Sciences (VCLS) is a global product development consultancy, which guides Biotechnology, Pharmaceutical and Medtech manufacturers throughout product development and commercialization. Its main objective is to support start-ups and innovators in the health sector through the means and implementation of their product development strategy, in order to drive commercial success.

Its outstanding team of health product specialists continuously supplement innovative life sciences companies’ resources with strategic advice and cross-functional operational capabilities. The firm offers unified solutions to development planning, manufacturing, quality and controls, nonclinical and clinical testing, safety monitoring, and cooperation with different regulators and health technology assessment agencies.

History
Voisin Consulting Life Sciences (VCLS) was founded in 1997 by  Dr. Emmanuelle M. Voisin ; a pharmacist with a Master of Advanced Study of patho-cell physiology and a PhD in pharmacology from Institut Gustave Roussy INSERM in 1984.

With more than 30 years of experience in drug development and an expertise in non-conventional development strategies, in Ile de France, Dr. Emmanuelle M. Voisin launches VCLS, to offer product development services tailored to the very specific needs of small Biotech companies.

Over the years, Emmanuelle assembled a team of accomplished industry professionals with complementary expertise to offer combined, strategic and operational capabilities in order to address the needs of health products developers. Since then, the firm has become a leading advisor to Biotech, Pharma and Medtech manufacturers for the development, registration and launch of innovative medical technologies across international markets.

The globalization of the sector has led the company to rapidly develop Internationally. In 2004, the firm opened their first office in Switzerland, and settled on the American market in Cambridge in 2005. In 2007, it opened another office in India, and also one in California in December 2014.

The firm acquired Regulatory Resources Group in the UK in 2013, and B & H Consulting Services in the US market in October 2015, in order to enhance its capacities on regulatory issues.

VCLS Expansion and Internationalization
The Regulatory Resources Group (RRG) is one of the longest established independent regulatory consultancies in Europe and it is based in Camberley, UK. The firm provides a large range of regulatory and development services for drug products, medical devices and drug-device combinations in several therapeutic areas. It was acquired by VCLS in 2013 which served to consolidate VCLS service range notably in regulatory science, interim management and training services.

B&H Consulting Services, Inc. is a U.S. based regulatory service firm located in Somerville, NJ. It was acquired by Voisin Consulting Life Services (VCLS) in 2015 forming one of the largest and leading independent consulting groups delivering high-end regulatory services to support interactions with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other global health agencies. B&H Consulting Services reinforces VCLS’ capabilities with in-depth controls expertise, strategic and operational support for all regulatory submissions as well as electronic publishing services in the U.S.

In 2018, Voisin Consulting Life Services creates its innovation center – Neighborhood. This firm supports health tech companies by providing strategic mentorship, resources and office space for growth in the biotech and medtech industries.

Key Activities
The firm focuses on helping the health tech sector grow and thrive by using expertise and experiences. The company’s regulatory and health economic expert resources in the U.S. and Europe have been supporting many clients with a wide range of services for the past 20 years.


 * Regulatory Science
 * Design and implementation of global regulatory strategies to ensure expedited product development and marketing. Create clinical and regulatory documents to support all stages of your drug and device development.
 * Market Access
 * Integration of payers perspectives and evidence requirements into health tech products’ development programs and regulatory processes.
 * Clinical Trial Submission and Operations
 * Offer flexible tailored clinical development optimization services from clinical designs to regulatory maintenance.
 * Chemistry, Manufacturing and Control (CMC)
 * Implementation of an effective CMC regulatory compliance strategy that can meet both FDA and/or EMA requirements and expectations
 * Publishing and Submission
 * Assemble and publish regulatory submissions for initial registration applications and throughout the product life cycle.