Regulatory Consulting
RO+ provides a full range of regulatory support services for your pre- and
post-marketing medical device development needs. Our experts adopt best practices while remaining on
top of the ever-changing regulatory landscape, meeting current demands in the following areas:
In-country representation
Legal
Representation
EC Authorized Representation
Regulatory submissions
Ethical
Committee and Site-level EC submission support
ANVISA and other country-specific review boards
Clinical Safety
Safety Management
Plan creation/review
Adverse Event Management
Preparation of Regulatory Reports
Expedited
and periodic reporting
Regulatory Compliance Tracking
Data Safety Monitoring Board (DSMB)
and Clinical
Event Committees (CEC) services
Post-Marketing Surveillance
(PMS)
Literature and Media Publications Review
Post-Market Clinical Follow-up
Studies
Regulatory Medical Writing and Medical
Communication
Benefit Risk Assessment Report
Investigator Newsletter
Literature
Summary
Manuscript
Narratives
Risk Management Plan
White Paper