Our Services
Our services include drug candidate selection, identifying studies necessary for approval and gap analysis, regulatory writing, support, and submissions, and risk assessment, in addition to the small stuff.
Gad Consulting Services has evaluated thousands of molecules for human and animal toxicity and compliance with regulatory standards. We have evaluated drug candidate molecules, marketed drugs both small molecule & biologics, impurities, process intermediates, degradants, leachables, excipients, residual solvents, and extractables, and our experience in medical devices includes both common and novel materials as well as changes in material manufacturing process when developing a product. Both known and unknown compounds can be evaluated using a combination of full literature searches (for known molecules), QSAR (Quantitative Structure-Activity Relationship) evaluations (for novel compounds) and read across methods. Searches of both public and proprietary databases, along with our extensive experience with compound toxicity evaluation.
We are here to help your company be successful and offer services tailored to meet your needs, even if your need is onsite training to learn to bring these services in-house. Solving unique safety problems is our specialty.