Telic, S.A.U.

IGAVIA SCIENCE is a full-service FDA regulatory consulting firm providing comprehensive regulatory compliance and product approval services for medical devices, in vitro diagnostics (IVD), over-the-counter (OTC) products, and cosmetics. The firm offers end-to-end regulatory support spanning 510(k) submissions, FDA registration and renewal, establishment registration, UDI submission, device listing, and U.S. Agent representation. Services extend to international markets including Mexico (COFEPRIS), Brazil (ANVISA), Argentina (ANMAT), Ecuador (ARCSA), Panama (MINSA), and Colombia (INVIMA). IGAVIA combines regulatory expertise with product engineering capabilities, providing strategic regulatory planning, device labeling and compliance review, cosmetic ingredient assessment, and quality management system implementation. The company operates a Medical Device Training Academy offering specialized online and customized courses in medical device regulations, quality management systems, and product compliance for professionals in device development, manufacturing, and distribution industries.