Navigating the regulatory landscape for FDA-regulated products is a complex and critical process. At Asebey Life Science Law, we provide expert legal guidance to ensure that our clients achieve the necessary regulatory clearances and approvals efficiently and effectively. Our scientifically-trained attorneys are adept at developing tailored strategies to meet regulatory requirements and expedite market entry.
We assist clients in every stage of the regulatory process, from initial strategy development to final submission and approval. Our services include preparing for pre-IND meetings, submitting IND applications to the FDA, and managing NDA, ANDA, and 505(b)(2) submissions. We also provide comprehensive support for medical device clearances, including 510(k) and PMA submissions, as well as Class I device listings.
Our expertise extends to OTC drug listings, BLA and biosimilar license preparation, and submissions. We also handle new dietary ingredient notifications (NDIN), GRAS notification dossier preparations, 30-day notifications for structure/function claims, and food additive petitions. Additionally, we assist with cosmetic facility registrations, IVD regulatory clearances, and DEA license applications.