Our AIM is to add value with benefits & to compete successfully.

IRQS is a consulting firm that establishes correct processes and repairs broken processes.

We focus mainly on FDA regulated companies in the pharma, biotech, medical device, and neutraceutical industries including start-ups. We also work with manufacturing companies in a variety of product areas.
For start-ups and companies desiring to benefit by establishing quality operations we offer the additional service of initiating your regulatory and/or quality systems.

We have developed insightful practices for broken interactions among key non-production processes. These include; marketing, R&D (design), regulatory/quality, risk management, CAPA, audits, and software processes. In our experience, these processes can contribute more to ROI, greatly aid business viability, and reduce consumer risk when operating without disconnects.

We will also develop and lead risk management and validation activities in any of the above including software processes. IRQS realizes that not every company needs or desires an optimizing effort across departments. So we offer an improvement service where we will analyze and optimize a single process usually a regulatory, or quality related process, although we will improve business functions like marketing. These improvement efforts are aimed at typical processes that can increase ROI, or reduce regulatory/business risk, but are not performing to expectation.

IRQS provides targeted, practical, measurable results for you.

The mainstay of our business is implementing FDA/ISO Quality Systems. We greatly enjoy the challenge in understanding processes involving new companies, new products. This is why we stay in business. We tailor a custom Quality System to the client. We implement flexible systems that can be adapted to circumstances as companies grow and change. IRQS learns your processes and fits the regulations and standards to them. We do not force fit a regulation or standard to a client QMS. Whether your company is a start-up ready for its first Quality System or an established company looking for better ROI in the economic conditions we see today.

IRQS will implement the Quality System that you want and need.