Built on Integrity.
Rooted in Puerto Rico.
IntegriPath Inc. was founded with a singular purpose: to be the life sciences partner that Puerto Rico's BioPharma and medical device industry deserves — one that combines deep regulatory expertise, uncompromising quality standards, and genuine commitment to client success.
Navigating the Path Between Compliance and Commerce
IntegriPath Inc. is a Puerto Rico-based professional services firm specializing in regulatory affairs, quality systems, and clinical services for the life sciences industry. We serve biotechnology, pharmaceutical, and medical device companies operating in — or looking to enter — Puerto Rico's dynamic manufacturing and research ecosystem.
Our team brings over 30 years of combined industry experience, with deep expertise in FDA regulatory pathways, ISO quality management systems, and clinical trial management across Puerto Rico's network of 64+ hospitals and clinics.
We are bilingual, deeply embedded in the Puerto Rico life sciences community, and uniquely positioned to bridge the gap between Caribbean manufacturing excellence and the global compliance standards that define success in today's regulated industries.
"To empower life sciences companies in Puerto Rico with the regulatory expertise, quality frameworks, and clinical capabilities they need to bring safe, effective products to patients — with integrity at every step."
To be the most trusted regulatory and quality partner in Puerto Rico's life sciences sector — recognized for our expertise, our integrity, and our unwavering commitment to client success and patient safety.
Proudly Puerto Rican. Globally Capable.
Puerto Rico is not just where we operate — it is who we are. The island is home to more than 50 BioPharma and medical device manufacturing facilities, 64+ hospitals and clinics participating in clinical research, and over 200 industry-sponsored clinical trials annually.
As a U.S. territory, Puerto Rico operates under FDA jurisdiction — making it a uniquely strategic location for companies seeking U.S. regulatory compliance while benefiting from a skilled, bilingual workforce and a lower cost of operations.
Our Core Values
Integrity
Our name says it all. Every engagement is guided by honesty, transparency, and an unwavering commitment to doing what is right — for our clients, their patients, and the industry.
Excellence
We hold ourselves to the same rigorous standards we help our clients achieve. Our work product is thorough, defensible, and built to withstand the highest levels of regulatory scrutiny.
Global Perspective
Puerto Rico sits at the intersection of U.S. regulatory jurisdiction and global manufacturing. We bring an international lens to every engagement, connecting local expertise with global standards.
Partnership
We work as an extension of your team — not as outside consultants. Your goals become our goals, and your success is the measure of ours.
The Credentials That Back Our Commitments
Our team holds industry-recognized certifications and brings hands-on experience across the full spectrum of regulatory, quality, and clinical disciplines. We stay current with evolving FDA guidance, ICH guidelines, and international standards so our clients don't have to.
- FDA Regulatory Affairs Certified (RAC)
- Certified Quality Auditor (CQA)
- ICH Q8/Q9/Q10 Pharmaceutical Quality Systems
- ISO 13485 Lead Auditor Certified
- GCP Certified Clinical Research Professionals
- Bilingual (English / Spanish) Service Delivery
- 21 CFR Parts 11, 210, 211, 820 Expertise
- EU MDR 2017/745 Technical Documentation
IntegriPath Inc. established in Puerto Rico to serve the island's growing life sciences sector.
Expanded service offerings to include full clinical trial management and site support across Puerto Rico's hospital network.
Established as a trusted partner for multinational BioPharma and medical device manufacturers operating in Puerto Rico.
30+ years of combined industry experience, serving clients across biotechnology, pharmaceutical, and medical device sectors.
Three Pillars of Life Sciences Expertise
Ready to work with Puerto Rico's trusted life sciences partner?
Let's discuss your regulatory, quality, or clinical needs — in English or Spanish.