CROMSOURCE Appoints Director of Regulatory Services and Expands Regulatory Operations
CROMSOURCE, an international contract research organization (CRO) providing a comprehensive portfolio of services to the pharmaceutical, biotechnology, and medical device industries, announced today the appointment of its Regulatory Services Department Director, Mr. David R. Dills, and the expansion of its Regulatory Services portfolio.
Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry. He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM's/sponsors, consultancies and a global CROs, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations.
David enjoys interpreting the regulatory precedents and new legislation, conducting due diligence, understanding the competitive landscape, developing the regulatory strategy and regulatory plan as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications, developing GxP compliance strategies and delivering regulatory training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific.
"Whatever the stage of clinical development, our clients need a partner that can provide the global regulatory capabilities to support their product portfolio for commercial success," said Dr. Margherita Mosconi, Chief Services Officer. "His tremendous broad experience will support CROMSOURCE in expanding its services into strategic regulatory consultation to biotechnology Companies."
Like CROMSOURCE, David can call on the wider scientific, medical and regulatory external expert network in specialized areas. Furthermore, the well-established connections with key regulatory experts permit CROMSOURCE to identify the best and defensible regulatory strategy for our clients.
Mr. Dills underscored that: "I do look forward to being part of the CROMSOURCE team and contributing to the company's ongoing and continuous success in the global marketplace and to be able to further support the increasingly complex product development needs of our global clients. We will offer and expand global regulatory services."
CROMSOURCE is an ISO-certified, international contract research organization providing a comprehensive portfolio of services to the pharmaceutical, biotechnology, and medical device industries. Specializing in clinical development and flexible resourcing solutions, they offer a flexible approach to ensure their clients' unique needs are supported. CROMSOURCE operates offices across all regions of Europe and North America.
For more information, visit http://www.cromsource.com.