Co-Founder of QRC Group. Licensed Chemist and Quality Certified Auditor (ASQ). Over 20 years in analytical laboratories and pharmaceutical Quality Assurance.
Regulatory Consulting Since 2005
Spurring Quality and Solutions
QRC Group, with over 20 years of experience in the industry, is the expert you need. We provide consulting services to pharmaceutical, medical device, biotechnology, and other regulated companies.
Since 2005 · HUBZone Certified · Offices in PR & FL · 130+ companies served
Services
QRC Group provides consulting services, since 2005, to pharmaceutical, medical device, and other regulated manufacturing companies.
Learn moreTraining
We reinforce our commitment to clients with training and learning opportunities, delivered at our facilities or on-site.
Learn moreCareers
Changing a career is changing your destiny. We see an employment decision as far more than a résumé.
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About Our
Company
QRC Group was founded in 2005 in Puerto Rico. We specialize in regulatory compliance and validation consulting for pharmaceutical, medical device, biotechnology, and regulated manufacturing industries.
We specialize in regulatory compliance and validation consulting for the pharmaceutical, medical device, biotechnology, and other regulated industries.
Over twenty years, QRC Group has delivered top-quality validation, regulatory, and compliance solutions.
Recognized as one of the top suppliers in the industry, providing the best resources for each project and comprehensive project management across every phase.
Read Our Story
Our
Mission & Vision
Mission
Provide our customers with the best resources and consulting services in the industry, using the most advanced and creative solutions to fulfill our clients' needs.
Vision
Become the undisputed service provider leader in the life sciences manufacturing field, and the go-to choice for clients and consultants alike.
Our Practice
Areas
Eight specialized practice areas covering the full regulatory and validation lifecycle, from qualification protocols to complete project execution.
130+Businesses Consulted
230+Active Connections
Quality Systems & Regulatory Compliance
CAPA, change control, GxP audits, document management, and business continuity for FDA, EMA, and EU GMP-regulated operations.
Learn moreFacilities & Utilities Qualification
IQ/OQ/PQ planning, protocols, and reports for HVAC, water systems, clean utilities, and classified manufacturing spaces.
Learn moreEquipment Qualification
21 CFR Part 11 assessments, computer system validation lifecycle, IQ/OQ/PQ for production equipment, and vendor audits.
Learn moreProcess & Cleaning Validation
Process validation lifecycle, gap analysis, cleaning validation, and swab recovery studies aligned to ICH Q7–Q12 and FDA guidance.
Learn moreQuality Control Labs
Method transfer and validation, chromatography software validation, and cGMP documentation review for QC laboratories.
Learn moreTraining & Documentation Management
Role-based GxP training, SOP authoring and lifecycle management, and documentation systems that pass FDA and EMA inspections.
Learn moreProject Management
Full project lifecycle for regulated facility builds, line transfers, and validation programs — initiation through closeout.
Learn moreImplementation Support
Embedded specialists who execute equipment, system, and platform upgrades inside regulated environments without disrupting operations.
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Our People
The QRC Team
Co-Founder of QRC Group. Over 20 years in manufacturing and the pharmaceutical industry.
Leads QRC’s project portfolio, aligning client engagements with strategic priorities and resources through governance, milestones, and audit-ready reporting.
20+ years leading technology services for regulated industries: enterprise applications, business solutions, digital transformation, and CSV governance.
Manages regulated-industry projects from planning through qualification, coordinating validation protocols, execution, and documentation for FDA, EMA, and EU GMP.
Leads validation and compliance projects, managing protocols, timelines, and resources with rigorous documentation and traceability for regulatory review.
With QRC since 2018 and 15+ years in accounting and human resources. Leads accounting management.
With QRC since 2018 and 30+ years across pharmaceutical and service industries. Designs organizational and operational training, procedures, and job curriculums.
With QRC since 2021 and 8+ years across administration, HR, training, recruitment, and payroll.
30 years in staffing: strategic sourcing, CV screening, candidate relations, interviewing, and talent assessment.
Ready to talk about your project?
Quality systems, validation, technology, or training — a QRC consultant will follow up within one business day.
Talk to a QRC Consultant