Monitoring the safety and effectiveness of your medical device after it has been commercialized requires the implementation of effective Post Approval Support processes. These strategies and activities are specifically designed to ensure the ongoing compliance of your product(s). Regulatory Compliance Associates® Inc. can help you design, implement, and execute a Post-Market Support Strategy including:
- Corrective and Preventive Action (CAPA) Support
- Root Cause Investigation
- Audit / Inspection Preparation and Remediation
- Labeling Review and Assessment
- Post-Market Surveillance (PMS)
- Medical Device Reporting / Adverse Event Reporting
- Recall Management
- Complaint Handling
- Re-submission Assessment and Remediation
- Post Approval Support
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.