Three Pillars of Life Sciences Expertise
IntegriPath delivers specialized regulatory, quality, and clinical services — bridging Caribbean manufacturing excellence with global compliance standards.
Regulatory Affairs
Navigate FDA & international regulatory pathways with confidence.
From IND applications to post-market surveillance, our regulatory experts guide your product through every stage of the approval process. We bring deep knowledge of FDA, EMA, and COFEPRIS requirements to accelerate your path to market.
- IND, NDA, BLA, and 510(k) submissions
- Pre-submission meetings and FDA interactions
- Regulatory strategy and gap analysis
- Labeling and promotional material review
- CMC writing and review
- International regulatory submissions
Quality Systems
Build quality frameworks that withstand regulatory scrutiny.
We design, implement, and optimize Quality Management Systems aligned with ISO 9001, ISO 13485, 21 CFR Part 820, and cGMP standards. Our approach ensures your quality systems are audit-ready and operationally effective.
- QMS design and implementation
- ISO 9001 and ISO 13485 certification support
- 21 CFR Part 820 compliance
- Internal and supplier audits
- CAPA management and root cause analysis
- Training programs and SOPs
Clinical Services
End-to-end clinical trial support across Puerto Rico's 64+ sites.
Leveraging Puerto Rico's unique position as a clinical research hub — with 64+ hospitals and clinics and 200+ industry-sponsored trials annually — we provide comprehensive clinical trial management, site support, and regulatory coordination.
- Clinical trial protocol development
- Site selection and management
- IRB and regulatory submissions
- Data integrity and monitoring
- Phase I–IV trial support
- Biostatistics and clinical reporting