It is not the thought of the regulators' next visit keeping you up at night; it's knowing you’re not ready.
At GCI, we have successfully resolved numerous regulatory challenges for clients, both at national and international levels.
We utilize proven methods to improve quality and regulatory systems and processes within your organization. We guarantee that your quality systems will be compliant with FDA and EU regulations so that you can continue to grow your company while maintaining a solid reputation and increasing your overall profit. Regardless of what your regulatory affairs issue may be, We stand ready to apply benchmarked solutions to your situation. We know how to remediate your gaps effectively and efficiently.
Backlog of complaints and MDR filings?
We will work with you to address backlogs in complaint investigations and MDR filings. We can bring a team on-site to assist in this critical task or we can work off-site from our office. Whatever you need, we have the ability to make it happen as quickly as you contact us.
Stressed about potential delays in new product approvals?
We work directly with Regulatory Affairs professionals that feel pressure from the corporation to address regulatory actions before they become critical – resulting in barriers to new product approvals. We will perform a complete analysis of your practices before implementing a successful strategy to get your company in line with regulatory requirements.
Concerned your existing records won’t hold up in an audit?
Together, we work with Regulatory Affairs leaders to ensure technical documentation is maintained to current standards and regulations. Our ultimate goal is the achievement or maintenance of your CE Mark or FDA/EU audit with zero observations.
Our RA services include:
- Audits and audit readiness (GMP/QSR, MDD/ISO 13485)
- Quality Procedures
- ISO certification
- CE Mark
- Technical Files
- Design Dossiers
- Gap Analysis
- Design History Files
- Ninshos & Shonins
- Phthalate and material characterization studies for product registrations
- Updates to current standards so your ERCs and DoCs can be authorized
With GCI, you’ll get the immediate results you’re looking for. Contact us today.
Former FDA Supervisory Investigator
Former CFO, Biomet 3i
“Roberta Goode was introduced to our company at a critical time when we needed strategic quality system guidance and hands on support. Roberta and the Goode consulting team provided immediate assistance and played a key role in leading our company to a best practices state. The GCI team possess’ high levels of competency and experience in specific technical areas. ”
Lorraine M. Hanley
Vice President – Global Regulatory Affairs, Navilyst Medical Inc.
Daniel L. Liberacki
Program Management Office, Orthopedics Medical Device Manufacturer
Director of Operations, Abbott Vascular
Certification Officer, TUV Rheinland of North America, Inc.
“GCI possess the skills and knowledge required for quality and regulatory systems, while displaying the utmost professionalism. GCI’s disposition instills confidence, trust and security clients will be seeking.”
Director of Quality Assurance, Boston Scientific Corp.
“GCI provides great leadership and consistently meet the commitments they make. Their greatest strength is the understanding of industry requirements and applying them to everyday applications. I strongly recommend GCI for any opportunity within the Medical Device Industry.”