Welcome to Catain

About Catain

At Catain, we specialize in guiding pharmaceutical, biotechnology, and healthcare companies through the complex U.S. regulatory landscape. Our mission is simple: to make FDA compliance straightforward, reliable, and efficient.

With years of expertise in ANDA, 505(b)(2), IND, NDC, FEI, GDUFA, and eCTD submissions, we provide end-to-end regulatory support tailored to your business needs. Whether you’re a startup bringing your first product to market or an established company managing global portfolios, our team ensures that every submission is accurate, compliant, and on time.

We pride ourselves on being more than consultants—we’re your regulatory partner, helping you minimize risks, reduce delays, and achieve approvals with confidence.