Regulatory Affairs

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.




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