L2M GLOBAL REGULATORY CONSULTING, PLLC Service OFFERINGS

FDA Regulatory Strategy / Product Classification
Premarket Notification [510(k)]
De Novo Classification Request
Premarket Approval (PMA) & PMA Supplements
Breakthrough Device Designation Request
Emergency Use Authorization (EUA)
513(g) Request for Information
Investigational Device Exemption (IDE)
Humanitarian Use Designation (HUD) / Humanitarian Device Exemption (HDE)
FDA Presubmission Meetings
Responses to FDA Requests for Additional Information (AINN)
FDA Registration and Device Listing
Remediation / Re-submission of Global Regulatory Documentation and/or Product Submissions

Global Regulatory Strategy / Product Classification
European Union Medical Device Regulations & In Vitro Diagnostics Regulations (EU MDR / EU IVDR) Technical Documentation, Clinical Evaluation Reports (CER), Post-Market Surveillance (PMS) Documentation for CE Marking
United Kingdom Medicines and Healthcare Products Regulatory Agency (UK MHRA) UKCA Marking and Registration
Health Canada Medical Device Licenses / Amendments
Australia Therapeutic Goods Administration (TGA) - Australian Register of Therapeutic Goods (ARTG) Listing / Registration

Japan Pharmaceutical and Medical Devices Agency (PMDA) / Ministry of Health, Labor, and Welfare (MHLW) Submissions / Registration
China National Medical Products Administration (NMPA) Submissions / Registration
Brazil National Health Surveillance Agency (ANVISA) and other Latin American Countries Submissions / Registration
Middle Eastern Medical Device Submissions / Registration
Global Regulatory Agency Presubmission / Early Collaboration Meetings

CLFDA 483 Observations
FDA Warning Letters
FDA Consent Decree
Deferred Prosecution Agreements (DPA) Implementation
Corporate Integrity Agreement (CIA) Implementation
Development and Implementation of Corporate Compliance Programs per Office of Inspector General (OIG) Guidelines
Compliance Training including Foreign Corrupt Practices Act (FCPA) / Physician Payment Sunshine Act
Compliance Investigations
Product Claims Review / Claims Substantiation Assessment

Expert Witness for FDA & Global Medical Device Regulations, Regulatory Submissions and Quality Management System (QMS) Requirements
Regulatory Subject Matter Expertise for the Review and Analyses of Deposition and/or Trial Testimony
Legal Document Review for Litigation Matters related to FDA Regulations and Medical Device Products Liability
Preparation of Expert Reports
Data Evaluation / Medical Device Research