GMP pharmaceutical services · Puerto Rico
Commissioning and qualification, computer system validation, and data integrity for FDA-regulated manufacturing sites, delivered by specialists who have spent their careers on the plant floor.
40+
Combined years
On-site pharma experience
Hundreds
of systems validated
Equipment, utilities and facilities
0
Major findings
FDA and international inspections
Who we are
Aegis Pharma Group specializes in Commissioning, Decommissioning, Computer System Validation (CSV), and Equipment, Utilities and Facility Qualification.
We support GMP and GLP compliance activities and hold deep expertise in Data Integrity, aligned with 21 CFR Part 11, EU Annex 11, and ALCOA++ principles, so your data environments stay secure, accurate, and audit-ready.
Our team comes from decades of continuous, on-site experience at major FDA-regulated manufacturing sites across Puerto Rico. That is where the technical depth, regulatory expertise, and institutional knowledge come from.
Our services
IQ/OQ/PQ authorship and field execution across manufacturing, parenteral, and packaging departments, covering equipment, laboratory instruments, utilities, and facilities per applicable regulations and site requirements.
Systematic retirement of equipment and systems with complete risk assessments, documentation packages, and regulatory closure under GMP requirements.
Full GxP lifecycle: 21 CFR Part 11, EU Annex 11, GAMP 5, Analytical Instrument Qualification (AIQ), electronic records, and computerized system audits.
ALCOA++ gap assessments and remediation, audit-ready electronic data environments, Annex 11 compliance, and data governance program support.
End-to-end change control management, Corrective Actions coordination, GMP/GLP gap assessments, and regulatory inspection preparation and on-site support.
A remote technical documentation expert for protocol authorship, Impact Assessments, CARAs, Change Management, and deviation closure.
Systems our documentation team works in
Regulatory alignment
ALCOA++
Every protocol we author, every record we handle, and every system we validate is governed by ALCOA++.
Why Aegis
Our specialists are not external consultants. They are embedded professionals who built their careers inside regulated pharmaceutical manufacturing facilities in Puerto Rico, working daily alongside engineering, manufacturing, and QA teams.
Deliverables authored and executed by our team across C&Q, CSV, Data Integrity, and compliance activities have withstood FDA and international regulatory inspections with zero major GMP observations.
From commissioning and decommissioning through CSV, Data Integrity, change control, and GMP/GLP compliance, our team provides end-to-end pharmaceutical services without handoff gaps or third-party dependencies.
Client site experience
Janssen Ortho LLC & Janssen Cilag LLC
Gurabo, Puerto Rico · Johnson & Johnson Innovative Medicine
Our senior specialists have maintained a continuous, embedded presence at Janssen Gurabo, delivering C&Q (IQ/OQ/PQ) along with CSV, Data Integrity assessments, change control management, and GMP compliance support.
All deliverables have withstood FDA and international regulatory inspections with zero major observations.
Our team approach
A structured model built for quality oversight, field coverage, and documentation excellence.
Lead protocol authorship, change control, project management, QA alignment, and regulatory inspection support. 20+ years of pharmaceutical experience per specialist.
Execute qualification deliverables in the field under senior guidance, enabling concurrent coverage across multiple active projects at the site.
A dedicated technical documentation expert for document management, change control coordination, and audit-ready documentation closure.
Log your hours by pay period and submit them for approval in the team portal.
Contact
Tell us about the site, the systems, and the timeline. You will talk directly with the person who leads the work.
Jonathan A. Hernandez Algarin
Principal Consultant & Owner · Aegis Pharma Group Inc.
