Regulatory Document Preparation Consulting

When your company requires dependable regulatory document preparation for a new or established product, put your trust in Regulatory and Technical Associates, Inc (RTA). We specialize in regulatory document consulting and regulatory document preparation for our clients in the pharmaceutical, medical equipment, food, consumer products, cosmetic and chemical industries.

We are experienced in document preparation for numerous types of regulatory documents including INDs, NDAs, CTDs, 510(k)s, PMAs, Investigator Brochures, Robust Summaries, Food Additive Petitions and other regulatory documents that support product development and product registration. In addition, we routinely prepare position papers on issues of concern regarding preclinical safety and regulatory affairs which may be used to support regulatory submissions or the internal decision making process.

Position papers and regulatory document preparation is done by experienced, senior document preparation consultants who ensure successful results and on time performance for every project. We are sensitive to our clients’ deadlines, and understand that unexpected delays can be a major impediment to the product development process. We take great pride in our record of on time performance, which approaches 100%. The majority of our 510(k)s have been approved within 90 days of submission.

Our regulatory document preparation consultants each have over 35 years of experience in toxicology, preclinical research and regulatory affairs. Additionally, they are board certified by multiple professional groups including the Regulatory Affairs Professional Society and the American Board of Toxicology. Regulatory and Technical Associates is registered as a US agent with the Food and Drug Administration.

For more information regarding how we can assist you in the preparation of your regulatory documents contact Dr. Robert J. Staab (phone: 860-434-5872;  email: rta1ali1@aol.com) or Dr. Daly (phone: 908-236-6834; email: idaly61127@aol.com).