Scientific Document Preparation & Medical Writing
Regulatory and Technical Associates (RTA) is a medical writing, scientific document preparation consulting organization that assists companies in medical writing and scientific document preparation of FDA focused 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, our medical writers and scientific document preparation consultants are routinely involved in the preparation of 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.
We have extensive consulting experience in toxicology, preclinical research, regulatory affairs, medical writing and scientific document preparation. We work with a wide range of companies in the pharmaceutical, medical device, food, consumer product, chemical and petroleum industries.
Regulatory documents and position papers are prepared by experienced senior 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 scientific consultants each have over 30 years of experience in toxicology, preclinical research and regulatory affairs, and 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 with medical writing, scientific document preparation and the preparation of your regulatory documents 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).