Regulatory Assistance

LexaMed provides regulatory compliance consulting services for clients from the pharmaceutical, medical device and nutritional supplement companies. LexaMed can assist in all areas of medical device, pharmaceutical and related industry compliance activities, including consulting on compliance and remediation action plans and strategies, assisting in new product submissions and registrations – FDA, EPA, EU, Canada Medical Device Regulations (MDR), Australia TGA, Brazil Anvisa, and conducting compliance audits against CFR 820, 210/211, 111, ISO 13485, 17025, Q7A, etc. LexaMed can also generate data in our ISO 13485 certified laboratory to support product submissions.