Sigma Biomedical

Sigma Biomedical provides complete regulatory consulting services for US FDA, Mexico COFEPRIS, Argentina ANMAT, Brazil ANVISA, and Colombia INVIMA product approval submissions, as well as support for other medical regulatory affair needs, such as product safety, engineering compliance, and Quality Management Systems implementation. Sigma's regulatory, engineering, and scientific team can efficiently help you achieve product approvals so you can reach US and international markets sooner than ever.

Sigma goes beyond traditional regulatory consulting giving you the extra advantage of a product engineering team that also assists in medical product development and testing. Sigma strives to provide customers with cost effective services, solutions and approval strategies ensuring that their products will receive approval without delays, thus maximizing return on investment. Our team of experienced engineers who understand the product development process will work with your team to bring all these promises to reality.