Gad Consulting Services is an internationally recognized consulting practice serving primarily the pharmaceutical, medical device, and dietary supplement industries in the areas of preclinical and early clinical evaluation, safety assessment, statistics, and risk assessment. The practice is primarily focused on technical and regulatory support of new product development and the technical support of existing products. The practice provides the full range of services in the areas of its expertise in an effective, flexible, reliable and timely manner.

Shayne C. Gad, Ph.D., DABT, ATS, the principal of the firm, has more than 35 years of broad-based experience in toxicology, drug and device development, statistics, and risk assessment. He has specific expertise in neurotoxicology, in vitro methods, inhalation toxicology, immunotoxicology, and genotoxicology. A past president of the American College of Toxicology and the Roundtable of Toxicology Consultants and the recipient of the 2008 ACT Lifetime Achievement Award, Dr. Gad has authored or edited 42 books, 52 independent chapters and more than 300 papers and abstracts in the above fields. He has contributed to and has meaningful personal experience with IND (93 successfully filed to date), NDA, BLA, ANDA, 510(k), IDE, CTD, dietary supplement and PMA preparation. Dr. Gad is fully experienced with the design, conduct, analysis, and reporting of preclinical and clinical safety and pharmacokinetic studies for drugs, devices combination products and dietary supplements, and with regulatory submissions associated with them.

Gad Consulting Services holds SAS, DEREK, METEOR, and Leadscope licenses and capabilities and has successfully qualified impurities, intermediates, residual solvent, and excipient levels in existing and under development drugs for many of its clients, as well as leachables and extractables for device clients.

Additional associated staff specializes in food and cosmetic safety and regulation, quality assurance, data management, analytical, medical writing, environmental and information services support. Referrals are gladly provided for work outside our areas of expertise.

Samantha E. Gad, Staff Chemical Engineer & Consulting Associate

Samantha received her B.S. in Chemical Engineering from University of Cincinnati in 2004. While in school she worked in water treatment, design engineering, and drug development.

Trained in areas such as six sigma, regulatory affairs, formulation, CMC, safety evaluation, pharmacokinetics. Has several publications and is a skilled instructor. Skilled in the use of Leadscope and DEREK QSAR, proprietary and on-line research databases and familiar with Oracle, software for material flow, inventory tracking and process design.

She began her career as a production leader in GMP manufacturing facilities. During this time she helped design processing systems and procedures, validate equipment for a new GMP processing facility. Samantha wrote Standard Operating Procedures (SOPs) for processing, shipping, receiving, training, audits and sanitation for the facility and created equipment, safety and procedural documents. During production, she led a group of 30 operators and did frequent work with product formulations.

Samantha joined Gad Consulting Services (GCS) permanently in 2009. Her work for clients of GCS is centered on chemistry manufacturing and controls (CMC). This work includes performing GMP audits for pharmaceuticals, medical devices and device materials (domestically and internationally), accessing safety of drug formulation and the biocompatibility of medical device material. She frequently reviews literature on leachables, extractables, degradants, impurities and residual solvents to determine acceptability criteria. Her Samantha helps with the selection and monitoring of vendors for outsourced development and manufacturing projects. She has taken the lead at Gad Consulting in the preparation, filing and upkeep of Investigational New Drug Applications (INDs) and drug master file (DMFs).