QRx Partners

QRx Partners provides regulatory affairs and quality system consulting services to medical device, pharmaceutical, biologics, and in-vitro diagnostics companies. The firm specializes in FDA and regulatory body interactions, quality management system development, and compliance auditing for healthcare product manufacturers.

The company offers six primary service areas: regulatory interaction support for FDA submissions and responses, quality system assessment and auditing, QMS development and improvement, education and training programs, fractional quality and regulatory leadership, and eQMS implementation services. Their client roster includes major healthcare manufacturers like 3M and Starkey, as well as emerging MedTech startups and digital therapeutics companies.

QRx Partners works across the healthcare product development lifecycle, from early-stage quality system establishment through regulatory remediation and ongoing compliance management. Their expertise spans multiple product categories including medical devices, pharmaceuticals, biologics, and diagnostic products.

Select QRx Partners when you need specialized regulatory and quality system expertise for healthcare product development and commercialization. The firm's fractional leadership model makes them particularly valuable for startups and small manufacturers who need senior-level compliance guidance without committing to full-time hires.

Expect comprehensive support across the regulatory lifecycle, from establishing initial quality systems through FDA submission preparation and regulatory body response management. Their multi-product expertise (devices, drugs, biologics, diagnostics) provides cross-industry regulatory perspective.

QRx Partners exclusively serves healthcare product manufacturers requiring FDA and regulatory compliance. Their practice focuses on the intersection of quality management and regulatory affairs for physical healthcare products including Class I-III medical devices, pharmaceutical formulations, biologics, and in-vitro diagnostic tests. The firm maintains expertise in 21 CFR Part 820, ISO 13485, and other healthcare-specific quality and regulatory frameworks required for product commercialization and market maintenance.

Medical device manufacturers, pharmaceutical developers, and diagnostics companies at any stage from startup through established manufacturer. Organizations preparing for FDA submissions, responding to regulatory findings, or establishing quality systems for the first time. Companies seeking senior regulatory expertise without full-time executive commitments.