SciRegís consultants provide the highest level of technical expertise combined with professional integrity. Relying upon extensive experience gained while working within product testing laboratories, government, and academia, and for pharmaceutical, pesticide, animal health, and chemical companies, SciReg provides its clients with practical, cost-effective, proactive, and goal-oriented consulting services.
Mr. James S. Damico
Mr. Damico is president and founder of SciReg, Inc. He has extensive experience and expertise in regulatory affairs, quality assurance, and scientific investigations pertaining to the regulation of agricultural and non-agricultural pesticides, and human/veterinary health products.
Mr. Damico is involved in all phases of SciRegís consulting services including expert witness testimony, product approval activities, and development and presentation of training programs in GLPs, veterinary GCPs, and regulatory compliance. He is also responsible for designing, monitoring, and quality assuring various clinical and non-clinical studies to support product approvals including analytical chemistry, residue chemistry, efficacy, environmental fate, ecotoxicity, worker exposure, target animal safety, mammalian toxicity, and mutagenicity studies. Further, Mr. Damico is intimately involved in development of alternative strategies to satisfy product approval requirements in the absence of complete data sets.
Before establishing SciReg, Mr. Damico was Manager of Regulatory Affairs at SRA International, Inc., a consulting firm where he implemented and oversaw the companyís product registration, approval, and testing processes. Mr. Damico began his career at Hazleton Laboratories, Inc. (now Covance Laboratories, Inc.), a leading contract toxicology, chemistry, and environmental testing firm. At Hazleton, he conducted acute, subchronic, chronic, teratogenicity, and reproduction toxicology studies and then served as a quality assurance supervisor managing the GLP audit activities of a team of auditors reviewing data generated to support FDA, EPA, and international product approvals.
Mr. Damico earned his bachelorís of science degree in biology from Virginia Polytechnic Institute and State University (Virginia Tech). He is an active member of the Society of Quality Assurance (SQA) and the National Capital Area Regional Society of Quality Assurance (NCARSQA). He is certified as a Registered Quality Assurance Professional in Good Laboratory Practices (RQAP-GLP). Mr. Damico has served on SQA's Regional Chapter Presidents Committee and as President, Vice President, Past President, Program Committee Chair, Nominating Committee Chair, and Corporate Relations Committee Chair for NCARSQA.
Mr. Frederick T. Smith
Mr. Smith has numerous years of experience in pesticide and chemical testing, quality assurance, and regulatory affairs. Mr. Smith provides a full range of regulatory services to clients requiring product approval/registration support.
Prior to joining SciReg, Mr. Smith was a senior consultant for ChemReg International, and a regulatory scientist for SRA International. Throughout his consulting career, Mr. Smith has worked with small start-up companies, mid-sized companies, and large, multi-nationals to obtain and maintain pesticide registrations for agricultural, antimicrobial, biochemical, and microbial products. Mr. Smith works extensively with novel, cutting-edge antimicrobial technologies and unique, new active ingredients.
Mr. Smith has developed client-specific registration strategies to expedite regulatory processes, placed and monitored hundreds of studies in a variety of scientific disciplines to support product registrations, conducted scientific and regulatory audits of reports and data, and served as an expert witness in data compensation arbitrations. He has also worked at Hazleton Laboratories, Inc. (now Covance Laboratories, Inc.) as a quality assurance auditor where he reviewed acute, subchronic, chronic, teratogenicity, reproduction, and mutagenicity data generated to support FDA and EPA product approvals. At Tegeris Laboratories, he served as a study coordinator conducting acute, subchronic, and chronic rodent and canine toxicology studies.
Mr. Smith earned his bachelorís of science degree in biology at the University of Maryland. He is an active member of the Society of Quality Assurance (SQA) and the National Capital Area Regional Society of Quality Assurance (NCARSQA).
Ms. Cinda L. Bell
Ms. Bell provides a full range of regulatory services to our EPA-, FDA-, and internationally-regulated clients. She has experience in regulatory compliance, quality assurance, and the conduct of studies required to support product approvals. Ms. Bell coordinates most of SciRegís quality assurance activities, including the review of studies for compliance with U.S. and international regulations and guidelines. She is also primarily responsible for implementing and presenting SciRegís GLP training programs.
Prior to joining SciReg, Ms. Bell was a study toxicologist for Covance Laboratories, Inc. In this role, she managed and coordinated activities related to the development, scheduling, performance, and reporting of GLP toxicology studies. Ms. Bell has also spent many years employed in various quality assurance positions where she was responsible for ensuring all aspects of regulatory compliance with the GLP (FDA, EPA, and OECD) and GMP regulations. These responsibilities included auditing study-specific data and reports, internal and external facility inspections, providing training and regulatory guidance to staff, and creating and implementing new and improved processes for increased compliance.
Ms. Bell earned her bachelorís of science degree in marine biology from Florida Institute of Technology and is currently enrolled in the masterís of science in bioscience regulatory affairs program at Johns Hopkins University. She is a member of the Society of Quality Assurance (SQA), a Director for the National Capital Area Regional Society of Quality Assurance (NCARSQA), and is certified as a Registered Quality Assurance Professional in GLPs (RQAP-GLP).