We provide expert FDA regulatory affairs services, guiding pharmaceutical and biotech companies through U.S. regulatory pathways. From IND and NDA submissions to lifecycle management, we ensure compliance, reduce approval risks, and accelerate time-to-market for your medical products.
A strong regulatory framework is essential to ensure the safety, efficacy, and quality of medicinal products throughout all stages—from pre-market development to post-market surveillance. In the United States, the Food and Drug Administration (FDA) serves as the primary regulatory authority overseeing medicines, medical devices, biosimilars, vaccines, dietary supplements, pharmacovigilance services, cosmetics, and more.
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