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Regulatory & Technical Associatesregulatoryandtechnicalassociates.com · Low evidenceRegulatory and Technical Associates, Inc. (RTA) is a consultancy specializing in toxicology, preclinical drug and medical device development, regulatory affairs, and quality management system development and support for clients across the pharmaceutical, medical device, cosmetic, food, consumer product, chemical, and petroleum industries worldwide. Their team includes board-certified experts and they provide regulatory submissions to the FDA and global regulatory bodies, including INDs, IND Annual Reports, NDAs, CTDs, IDEs, 510(k)s, PMAs, Food Additive Petitions, and GRAS determinations, and they serve as US agents for multiple companies—recognized in women's health. RTA also offers quality management system writing and auditing services and notes that many 510(k) approvals are achieved within about 90 days of submission.
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