Regulatory and Technical Associates, Inc. (RTA) stands as a distinguished consultancy specializing in toxicology, preclinical drug and medical device development, Quality Management System Development and Support as well as Regulatory Affairs. Our team comprises board-certified experts in toxicology, regulatory affairs, quality assurance and safety, boasting a wealth of experience in these fields. We serve both domestic and international clients, delivering top-tier consulting services.

Our sphere of focus encompasses the pharmaceutical, medical device, cosmetic, food, consumer product, chemical, and petroleum industries. RTA enjoys recognition as a foremost authority in women's reproductive health and proudly holds registration as a US Agent with the FDA.

Within the realm of toxicology, preclinical drug and medical device development, and regulatory activities, our mission centers on evaluating the safety of novel and established products. RTA possesses the requisite expertise to assist our clients in navigating the complex landscape of product development, addressing safety and regulatory concerns that significantly influence market entry.

As a routine practice, RTA prepares regulatory submissions for the FDA and various other global regulatory bodies. These submissions encompass a wide spectrum, including INDs, IND Annual Reports, NDAs, CTDs, IDEs, 510(k)s, PMAs, Food Additive Petitions, and GRAS determinations.

The journey of drug and medical device product development is rigorous, resource-intensive, and time-sensitive. RTA equips you with the indispensable support, experience, and guidance in toxicology, preclinical drug and medical device development, and regulatory affairs needed to usher your products successfully to market. Additionally, we offer comprehensive medical writing services.

Recognizing the paramount importance of our clients' timelines, we take pride in our ability to secure approvals for the majority of our 510(k)s within a mere 90 days of submission. With our assistance, clients can traverse the product development process seamlessly, steering clear of unwarranted delays. We encourage you to reach out and initiate a conversation about your project requirements.