Dennis M., an ex-FDA investigator with 28 years in the regulatory and compliance field, is currently Chief Technical Expert and Managing Partner. Dennis brings 28 years of experience in medical device design, software design validation systems and evaluations, manufacturing software validation including ERP systems and FDA Predicate rules and the 21 CFR Part 11 rules as they apply to device firm's quality systems. Dennis has extensive experience helping firms achieve compliance to FDA regulation and International Standards regulations. Recent achievements include CE marking a medical device, helping a previously vioaltive firm achieve a no FDA 483 outcome, helping create a Combination Product Quality System; co-authoring a Technical File submission, and achieving ISO 13485:2003 and ISO 9001:2008 certification for a medical device manufacturer.
Our Team of Former FDA Investigators and Staffers Ensure Compliance by Offering the Following Services:
FDA Compliance | Master Planning and Strategy Preparation for Inspections Pre-approval and Mock FDA Inspections Vendor / Supplier Audits Gap Analysis Formal Risk Assessment Support with 483′s / Warning Letters / Consent Decrees Assistance and Review of Regulatory Filings (IND's/PMA's/NDA's/ANDA's/BLA's/510(k)'s/etc.) Quality Systems Guidance and Development Corporate SOP Guidance and Development Mock Product Recalls Assistance with Product Recalls Process and Utility Design Review and Assessment Facility Layout Review and Assessment Dietary Supplements and Nutraceuticals Assistance with Imports 21 CFR Part 11 Compliance Strategies Validation Master Plans Equipment and Instrumentation Qualification Utilities Qualification Process Validation Cleaning Validation Analytical Methods Validation IT Qualification and Computer Validation Training and Development of Training Programs