RCB Services
Strategic Planning
Analyses and Recommendations to Meet Your Regulatory Needs
We provide Regulatory Planning that ensures optimization of
regulatory submissions
promotional communications
brand strategies
that fit your Company's specific needs for long-term regulatory compliance
Deliverables
510(k), PMA, IDE, and INDs
Establishment and Maintenance of CE Marks: Tech Files, Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up Reports (PMCF)
Navigation of global device registration
Labeling and Promotional Review
UDI System Strategy & Management
Post-Market Surveillance
Global Recall Coordination
IND, NDA, IDE, CSRs, BLAs
Management
We offer management of Regulatory Affairs departments with a focus on:
training
process and procedures
long-term regulatory compliance
Additional Services
Regulatory planning and long-term strategy
Remediation planning and execution
Corporate and Stakeholder communications