RTA: Excellence in Regulatory Scientific Consultation
A leading consulting firm specializing in regulatory affairs and toxicology supporting the regulatory and safety needs of the pharmaceutical, medical device, consumer product, cosmetic, food, chemical and petroleum industries.
AIRB: Allendale Investigational Review Board of RTA Inc.
We offer clinical protocol review services to Research Organizations and Contract Laboratories throughout the world.
Toxicology Preclinical Drug and Medical Device Development Regulatory Affairs
Regulatory and Technical Associates, Inc. (RTA) is a toxicology, preclinical drug and medical device development and regulatory affairs consulting company that specializes in a wide range of development activities. Our consultants are Board Certified in toxicology, regulatory affairs and safety and have years of experience in toxicology, preclinical drug and medical device development, and regulatory affairs. We work with domestic and international clients and provide superior, consulting service.
We focus our attention on the needs of our clients in the pharmaceutical, medical device, cosmetic, food, consumer product, chemical and petroleum industries. We are recognized as a leading expert in women’s reproductive health and are registered as a US Agent with the FDA.
Our toxicology, preclinical drug and medical device development and regulatory activities focus on the safety evaluation of new and established products. RTA has the necessary experience in toxicology, preclinical drug development and regulatory affairs to assist our clients’ address the product development safety and regulatory issues that directly impact their ability to bring their products to market.
RTA routinely prepares regulatory submissions for the FDA and other worldwide regulatory agencies. These include INDs, IND Annual Reports, NDAs, CTDs, IDEs, 510(k)s, and PMAs, Food Additive Petitions and GRAS determinations.
Drug and medical device product development is a rigorous, labor intensive and time-consuming process. RTA provides you with the experience, support and consultation in toxicology, preclinical drug and medical device development and regulatory affairs necessary to bring your products to market. We also provide extensive medical writing services.
RTA is extremely sensitive to our client’s timelines. The majority of our 510(k)s have been approved within 90 days of submission. With our assistance our clients are able to navigate the product development process without facing unnecessary delays. We encourage you to contact us and let us discuss your project needs.