ECI-Rx is able to put together an experienced project team of subject-matter experts from our global pool of consultants to work alongside local teams on regulatory compliance cases.
Our regulatory experts stay up to date on current requirements and protocols in the often rapidly changing regulatory environment. With proven experience, we are able to gain compliance for our clients’ products under challenging conditions and faced with aggressive deadlines.
- Consent Decree/Warning Letter
- Quality Audits
- Quality System Gap Analysis
- Quality System Integration
- Quality System Certification
- Corrective Action, Preventative Action CAPA/Root Cause Analysis
- Complaint Investigation
- Product Recalls
- Technical File/DD/DMR/DHF Remediation
- Risk Management
- Annual Product Review
- Audit Responses
- Regulatory Affairs Consulting
- Corporate Training
The True Cost of Non-Compliance
Companies often choose to delay large-scale compliance efforts due to a variety of factors. But are you aware of the true cost of non-compliance and the lasting negative impacts it can have on the success of your product and the long-term heath of your business?
At Enhanced Compliance Inc. we call this the “elephant in the boardroom.” But not talking about it – and not taking action – will not make your non-compliance issues go away.
Contact ECI-Rx for streamlined cost-efficient compliance management and compliance remediation services.