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.

RE/MAX Classic Puerto Rico delivers top-tier real estate services through a dedicated team of professional agents. Our commitment to quality customer service, deep knowledge of the local market, and continuous training are the cornerstones of the exceptional and timeless service we provide. We lead the local market by upholding the highest ethical standards and offering personalized attention to every client.

Ricoh Puerto Rico es una empresa manufacturera y líder en impresión comercial y soluciones tecnológicas para el lugar de trabajo.
Llevamos más de 55 años sirviendo a las empresas locales, con cobertura en toda la isla y un equipo de más de 79 técnicos dedicados que nos permite responder con rapidez y cercanía a las necesidades de nuestros clientes.

Con una sólida trayectoria en Puerto Rico y el respaldo global de Ricoh, ayudamos a las organizaciones a optimizar sus procesos, mejorar la productividad y modernizar sus entornos de trabajo, integrando la mejor tecnología para transformar sus espacios de oficina.

Soluciones principales
Gestión Documental y Automatización
Digitalización de documentos, flujos de trabajo automatizados y sistemas de gestión electrónica.
Servicios Administrados de Impresión
Optimización del parque de impresión, control de costos y seguridad de documentos.
Equipos y Tecnología de Oficina
Impresoras, multifuncionales, producción gráfica, escáneres y equipos interactivos.
Transformación Digital y Servicios Cloud
Herramientas de colaboración, migración a la nube y soporte a modelos de trabajo híbrido.
Servicios de TI y Ciberseguridad
Monitoreo, soporte administrado, infraestructura y protección de datos.
ProAV y Comunicación Colaborativa
Salas de conferencia inteligentes, soluciones de videoconferencia y señalización digital.

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Locally, RSM Puerto Rico is the third largest accounting and consulting firm. Globally, RSM is the sixth largest provider of assurance, tax and consulting services.

Our vision is to be the premier professional services provider, known for delivering lasting value and confidence.

RSM Puerto Rico is member of the RSM Network leveraging global resources and putting them at your service.

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ECIJA SBGB, a law firm based in Puerto Rico, offering a diverse range of services, including the establishment of foreign entities investing in Puerto Rico. We cater to clients across various sizes and industries. From up-and-coming start-ups to well-established multinational companies, commercial banks, government entities and non-profits, investors seeking to benefit from Puerto Rico Act 60 (formerly Acts 20 and 22) tax incentives, and international energy companies. Our firm’s capabilities allow us to advise clients on a wide range of matters related to Financial Law, Tax Law, Corporate Governance, Real Estate (including pre-development), Mergers and Acquisitions, Joint Ventures and strategic investments, Corporate Finance, Tax Exemption and Estate Planning, as well as other general corporate matters, such as periodic corporate filings, financial reporting, and regulatory compliance. ECIJA SBGB also advises private equity firms and their portfolio companies for all aspects of their operational cycle and represents local and multinational companies in connection with major public infrastructure projects in areas of energy, low-income housing, and transportation transactions.