All those who in the field of production of new products in the market and looking for a genuine company that offer regulatory consulting services shall stop for a while and have a glance through the information below. There are companies in the market but Sigma Biomedical is one of the renowned FDA regulatory consultants known for offering regulatory services for Argentina ANMAT, US FDA, Columbia INVIMA, Mexico COFEPRIS and other product approval submissions. Apart from this the company also offers support to serve medical regulatory affair needs that include implementation of quality management systems, product safety, engineering compliance and much more. the company has years of experience in the field and the team associated with it is well trained, qualified and experienced helping you to achieve your goals of product approval to reach US and other international markets as soon as possible. To know about the company in further detail and the services areas under its coverage you can go through the website sigmabiomedical.com.

All those who are in this field know that it is essential that all the products are listed and cleared by the FDA before they are introduced to the US market. To make this procedure easy and quick you can approach the company, as it shall help you in achieving the same without making much effort.

It is the FDA consults associated with Sigma Biomedical who offering FDA consulting services in medical device registration while looking into FDA regulatory consulting services and approval process as well. The whole process of product approval, listing, business registration along with compliance with FDA regulations is done in an easy and cost effective way.

Also, manufacturers/distributors have to submit a 510K permanent notification/ pre market approval document to FDA, as this helps in clearance to follow & stay in compliance with QSR regulations for smooth distribution and marketing of products. Approaching the company for 510K submission and getting the approval for the same to proceed further is a wise decision. So, anytime you need services assistance for regulatory, quality, contract R&D, compliance and other areas you can approach the company directly.

Contact Us:
Sigma Biomedical
Address: 7600 NW 69th Avenue, Medley, FL 33166, USA
Phone: (305) 925-0843
Fax: (305) 925-1269
Email: [email protected]
Website: http://www.sigmabiomedical.com/