Falcon Consulting Group was created in 1999 as a services company. The initial focus of the firm was to provide technology and document management expertise. Within just a few years Falcon had established a strong reputation within the Life Sciences Industry for providing high quality and unbiased consulting with a primary focus on the selection and implementation of Electronic Document Management Systems (EDMS). In response to Falcon's growing reputation, in 2003 Falcon began providing services in the area of Good Clinical Practice (GCP). The level of experience and quality provided in this area of clinical quality assurance and clinical trial management quickly led to this service area becoming the largest service area within Falcon. Recently in 2010, Falcon has added remotely based employees in India, Romania, and Ireland. Throughout this continual growth, Falcon's stated strategy has remained to provide expert services within well-defined categories of client needs. As of June 1, 2012, Falcon added Regulatory Affairs to its already extensive list of services. Falcon can now bring considerable experience from pre and post marketing development through new product launches to our current and new clients. Our subject matter experts have been directly involved with numerous IND/CTA/INDS submissions and related regulatory project filings as well as being part of critical decisions regarding Go/No Go decisions at various tollgates. In addition, experience extends to global NDA/MAA/BLA and SNDA/variation submissions for major blockbuster products and content preparation/delivery at five (5) FDA advisory Committee meetings in multiple therapeutic areas.