Vice President, Programs
Laurel Hacche is a Senior Compliance Professional with over 25 years of experience in the pharmaceutical, device, and biologics industries. Dr. Hacche provides consulting services for the pharmaceutical, biotech, and medical device industries with a focus on third party assessment, qualification, and maintenance, quality assurance systems, compliance auditing, pre-approval inspection preparation, Corrective and Preventive Action (CAPA) systems, and GMP training. Prior to her role as a consultant, Dr. Hacche was the Senior Director of Third Party Manufacturing in the Global Sourcing & Procurement department at Allergan, Inc. During her tenure with Allergan, she served as the Director of Worldwide Quality Assurance with oversight for the corporate CAPA system, annual product reviews, government agency communication records, third party manufacturers, the global audit and stability programs, complaint management, and R&D technology transfer. In addition to the above activities, Dr. Hacche served as the lead corporate QA liaison for the FDA and alternate regulatory agencies. Prior to Dr. Hacche’s employment at Allergan, Inc., she served as a Postdoctoral Researcher in the Department of Biological Chemistry at the California College of Medicine at U.C. Irvine. Dr. Hacche has also held an Associate Faculty position at Saddleback College and served as an Assistant Professor at the Joint Science Department for the Claremont Colleges. Dr. Hacche holds a Ph.D. in Physical Polymer Chemistry from U.C. Irvine and an A.B. in Chemistry from Occidental College.
Vice President, Membership Ruchika Raval
Ruchika Raval is President of Global Biopharmaceutical Regulations (GBR Inc). GBR is a consulting firm that primarily focuses on helping companies strategize, plan and execute their Regulatory, and Quality Assurance program. GBR consultants represent industry experience from product development, process optimization to market research, regulatory research, dossier preparation, monitoring GXP compliance capable of supporting pre-IND through license application. GBR consultants are seasoned industry professionals and we offer costing options to sponsor company.
Prior to starting the consulting practice, Ms. Raval served in management roles at Chiron Vaccine, Bayer Biologics and Baxter Healthcare Corporation. Ms. Raval brings 30 years industry experience including research, audit, planning, and regulatory compliance and dossier preparation for US, EU and emerging markets. She is a former Board Member of Orange County Regulatory Affairs Discussion Group (OCRA), and current Board Member for Parenteral Drug Association (PDA-SoCal). Ruchika has been invited as a speaker at BioInvest, Regulatory Affairs Professional Society (RAPS), Drug Information Association (DIA) and PDA.
Under her leadership, GBR has been a certified Small Business 8(a) and Woman Owned Business by US Government and WBEC. The firm has served on NIH panel for vaccine research and review for the past 8 years.