Toxicology Program Placement and Management
Regulatory and Technical Associates, Inc. (RTA) is a consulting company with extensive experience in toxicology program placement and management within the Contract Research Organization (CRO) industry. Our consultants are Board Certified in Toxicology, Regulatory Affairs and Safety and have years of experience in toxicology, clinical research, and regulatory affairs.
We have extensive experience in all aspects of toxicology program placement and management including CRO selection, program design, implementation, conduct, data interpretation, monitoring and reporting. Regardless of whether testing calls for a single study or an entire testing program to support your regulatory submission RTA has the experience to address your needs working with an approved CRO or your own in-house testing facility. Our extensive knowledge of and experience with the CRO testing industry makes us ideally suited to assist you with all aspects of toxicology program placement and toxicology program management.
RTA has extensive experience with toxicology studies of all types including biocompatibility, safety pharmacology, toxicokinetics, local tolerance (irritation and sensitization), acute toxicity, repeat dose toxicity, in vitro and in vivo genotoxicity, reproductive and developmental toxicity, carcinogenicity and phototoxicity. RTA also has experience conducting programs to evaluate the toxicity of unique metabolites, product degradants and impurities. We are experienced with all large and small laboratory species and with all routes of administration.
We routinely assist our clients with any and all phases of study and program conduct including bid preparation, protocol development, CRO selection, study implementation, GLP compliance, test article characterization and dosing confirmation analysis, bioanalytical analysis and bioanalytical data evaluation, GLP and scientific monitoring of ongoing studies, data review, draft and final report review and regulatory submission. In addition, RTA is able to provide an experienced Study Director to support your in-house testing activities. We are also able to provide extensive report writing and regulatory submission capability.
RTA has the necessary experience in all aspects of toxicology program placement and management to assist our clients’ address the product development safety and regulatory issues that directly impact their ability to bring their products to market.
For more information regarding how we can assist you with your toxicology program placement and program management please contact Dr. Robert J. Staab (phone: 860-434-5872; email: rta1ali1@aol.com) or Dr. Ira Daly (phone: 908-236-6834; email: idaly61127@aol.com