Specialized Knowledge Across Life Sciences
IntegriPath brings deep, industry-specific expertise to biotechnology, pharmaceutical, and medical device companies — bridging Caribbean manufacturing excellence with global regulatory standards.
Biotechnology
From early-stage discovery to commercial launch.
Puerto Rico is home to a rapidly growing biotechnology sector, with world-class research institutions and a skilled scientific workforce. IntegriPath supports biotech innovators at every stage — from IND-enabling studies through BLA submissions and post-market lifecycle management.
We understand the unique regulatory and quality challenges facing biotech companies, including the complexity of biologics, gene therapies, and cell-based products. Our team brings deep ICH and FDA biologics expertise to accelerate your path to market.
How We Help
- BLA and biosimilar regulatory strategy
- IND preparation and FDA interactions
- Biologics CMC writing and review
- Quality systems for biologics manufacturing
- Phase I–III clinical trial support
- Post-approval lifecycle management
Pharmaceutical
Streamlining drug approval pathways and GMP compliance.
Puerto Rico is one of the world's leading pharmaceutical manufacturing hubs, producing nearly 25% of all U.S. FDA-approved drugs exported globally. With 50+ BioPharma and medical device manufacturing facilities on the island, the regulatory and quality demands are significant — and IntegriPath is uniquely positioned to meet them.
Our pharmaceutical team brings decades of experience with NDA, ANDA, and 505(b)(2) submissions, cGMP compliance, and FDA inspection readiness. We serve both multinational manufacturers and emerging local pharma companies across Puerto Rico.
How We Help
- NDA, ANDA, and 505(b)(2) submissions
- CMC writing and review
- cGMP compliance and gap assessments
- FDA inspection readiness
- Drug master file (DMF) preparation
- Pharmacovigilance and post-market support
Medical Devices
Navigating 510(k), PMA, and ISO 13485 with precision.
The medical device industry demands rigorous quality systems, precise regulatory submissions, and a deep understanding of both FDA and international requirements. IntegriPath guides device manufacturers through every stage — from design controls and risk management to 510(k) clearance, PMA approval, and EU MDR compliance.
Whether you're a startup bringing a Class II device to market or an established manufacturer managing a complex product portfolio, our team provides the regulatory and quality expertise to keep you compliant and competitive.
How We Help
- 510(k) and PMA submission preparation
- De Novo classification requests
- ISO 13485 QMS implementation
- 21 CFR Part 820 compliance
- EU MDR 2017/745 technical files
- Risk management per ISO 14971
The Caribbean's Life Sciences Powerhouse
Puerto Rico's life sciences ecosystem is one of the most dynamic in the world — combining U.S. regulatory jurisdiction, a world-class manufacturing base, and a growing clinical research infrastructure.
Ready to navigate your industry's regulatory landscape?
Our bilingual team brings industry-specific expertise to every engagement — in English and Spanish.