The Malvern Consulting Group leverages senior management’s over 30+ years of experience in forming companies, developing and commercializing products, and bringing companies public. Additionally, senior management has extensive background in big Pharma, in senior drug development, regulatory and marketing positions domestic and international. This experience base gives you and your team: An understanding of the financial and timing pressures your firm faces, milestones you must accomplish, as well as additional access to potential sources of capital; The on-the-ground experience and contacts necessary to complete your projects efficiently, saving valuable time and money; Direct experience building commercial organizations (sales, marketing, reimbursement) de novo or implementing expansions; Direct experience with creation of regulatory strategy and filings, and a success record for over 60 products in the US and EU; A broad base of experience in terms of therapeutic areas (drugs and biologics), devices and diagnostics; A broad base of contacts and the ability to provide high quality, timely and cost-efficient scientific advisory committee meetings, market research focus group meetings, etc.; Use of multi-media, including digital video and film production of media for: • Investigator and site personnel training • Physician/health care professionals education • Sales training • Use at meetings and conventions • Recording/editing of expert meetings Direct experience in setting up supply chains/sourcing/CMO selection for development or commercial stage products, as well as solving manufacturing, and quality issues; Providing “brainstorming” and the resources to implement planning for product life-cycle management. The Malvern Consulting Group is here to help you expand the size and expertise of your team without the need for permanent expansion.