Regulatory
-Regulatory and Technical Due Diligence for companies and investors;
-FDA Pre Market Clearances/ Approvals including, PMAs, PDPs, HDEs, IDE/IRBs, 510ks;
-Management representative for regulatory and clinical contacts including Notified Bodies, CROs, IRBs, and Investigators,
-Regulatory Inspection liaison with FDA for 483 responses, Warning Letters and Consent Decree Remediation Program Management.
- Determinations and “Letter’s to File” for product changes
-International medical device approvals, notifications and market clearances,
-Product labeling reviews
R&D
-Good Laboratory Practices programs and remediation
-Design controlled product development pathways and programs;
-pre IDE Animal testing protocols and programs
-Qualification of third party support and service groups
Operations Management
-Interim Regulatory and Quality Systems Management;
-Sensitive corporate communications with regulatory agencies, investors and the media
-Executive personnel qualification and procurement support
-Manage third party technical organizations
Quality Systems
-Audit, implement and train to QSR 21 CFR 820, 200, 211 and ISO 13485 requirements
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QSR Improvement Plan Program Management;
-Adverse Event, Vigilance Reporting, Corrective and Preventative Action Programs, Complaint Handling Systems, Failure Investigations.
-CE Mark and ISO 13485:2003 certifications
Engineering
-Installation, operational and performance qualifications
-Process, testing and product validations
-Facility design reviews
-Product sterilization validations
