Regulatory Affairs Services
Walker Downey & Associates, Inc. provides expert regulatory support through all of its service offerings. We are frequently asked to write Expert Opinions and Risk Assessments for the regulatory submissions of our clients, particularly in the medical device industry. Much of our current support concerns permanent implant devices and the justification for waiver of long-term (i.e., chronic toxicity and carcinogenicity) biocompatibility testing.
We can also, as required, represent our clients at their pre-submission meetings to discuss and defend preclinical/clinical strategies, pathology issues, and statistical analyses. Because of the high volume of medical device work that we do we are well recognized by FDA/CDRH, and our submission documents have been well received.
For additional information about how Walker Downey & Associates, Inc. can service your regulatory needs please contact us at firstname.lastname@example.orgCase Studies