Roger Soller Email & Phone Number

Dallas, Texas, Us

Biomedical Regulatory Consulting (BRC) is a Houston-based drug and device regulatory affairs company with extensive experience in product development of medical therapies and medical devices, including diagnostics and mobile health APPs.BRC creates and manages reliable, credible, cost-efficient, and time-dependable regulatory paths to market for drugs and medical devices. BRC also addresses gaps in clinical site management for clients, emphasizing effective deployment of a proven quality-system management structure.BRC Founder and President, Dr. Bill Soller, designed the BRC project team system to ensure the reliable deployment of credentialed experts, the application of strong central management oversight, and use of a proprietary quality control system for client deliverables. The parent company, sollerphd.com, provides law firms with expert witness services in the area of drug and device safety, pharmacoepidemiology, medical record review, off label use. See: http://www.sollerphd.com

October 2015 News Release: SRRS Restaged to BRC to Advance Continued GrowthOn October 16, 2015, Biomedical Regulatory Consulting (BRC) announced its new name, new look and new presentation of its comprehensive regulatory services. "What stays the same," said BRC President Dr. Bill Soller, "is our client-centered focus, and our promise of rigorous accountability to our clients and business partners." The expansion of regulatory consulting services under the BRC umbrella (formerly, Soller Regulatory & Research Services) comes at a time of increased interest by medical centers, physician entrepreneurs, and pharma companies to take advantage of outsourced regulatory services as an effective cost-saving strategy. "What sums up our success is this," add Soller, "...careful planning, regular sponsor contact on project advances, meeting timeline commitments, reasonable budgeting, and compliance with FDA and ICH requirements and guidances for all nonclinical and clinical activities. Add the regulatory wisdom of our highly experienced project teams and you get the BRC difference."

San Francisco, California, Us

Dr. Soller held senior management positions in regulatory and scientific affairs of major international pharma companies and a national pharma trade association. His principal activities related to successful team leadership of inter-industry task groups which addressed national safety, efficacy, labeling,technical (CMC), and preclinical and clinical support for product development of FDA regulated products. He is the principal author and submitter of over 100 FDA submissions on medical products, relating to safety, efficacy and labeling matters.

Phd, Medical Sciences

Postdoctoral Fellowship, Department Of Pharmacology, Neuropharmacology