QUGENERON LLC – Regulatory Excellence for Global Manufacturing Expansion

QUGENERON is a U.S.-based regulatory consulting firm led by former FDA regulators and seasoned quality professionals. As experts in pharmaceutical regulatory compliance and quality systems engineering, we specialize in guiding companies through the complex processes required to successfully establish and operate manufacturing facilities under the U.S. FDA regulatory framework.

We provide end-to-end support for new manufacturing ventures expanding to Puerto Rico, combining deep regulatory insight with operational execution. Our services are designed to ensure compliance, accelerate readiness, and reduce risk at every stage of setup and launch.

Our Core Services Include:

• FDA Regulatory Compliance & Inspection Readiness

  • Mock audits, 483/Warning Letter responses, and remediation strategy

  • Dossier preparation and FDA submission approvals

  • Development of inspection-resilient quality systems

• Facility Commissioning & Qualification

  • Support for facility design, commissioning, and validation in alignment with cGMP standards

  • Oversight of laboratory and cleanroom setup, environmental controls, and process validation

• Regulatory Filings & Incentive Decree Support (Puerto Rico)

  • Guidance and filing of Puerto Rico tax and economic incentive decrees (e.g., Act 60)

  • Fiscal compliance assistance for newly incorporated manufacturing entities

• Talent Recruitment & Workforce Outsourcing

  • Sourcing and placing top-tier talent, including engineers, quality professionals, and regulatory staff

  • Outsourcing solutions for quality, validation, and compliance functions

With over a decade of experience supporting global pharmaceutical operations—including clients in the U.S., India, Europe, and Asia—QUGENERON stands ready to serve as a strategic partner for manufacturers choosing Puerto Rico as their regulatory gateway to the U.S. market.

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