Pharma Solutions
Developing GxP-compliant pharmaceutical solutions that accelerate drug discovery, streamline clinical trials, and ensure regulatory compliance.
Our Approach
The pharmaceutical industry operates under some of the strictest regulations in the world. At Helomatrix, we build validated software systems for drug development, clinical trial management, pharmacovigilance, and supply chain tracking. Every line of code we write is documented, tested, and audit-ready for FDA 21 CFR Part 11 and EU Annex 11 compliance.
Challenges in Pharma
Regulatory Validation
Meeting FDA 21 CFR Part 11 and EU Annex 11 requirements for electronic records and signatures.
Clinical Data Management
Handling massive datasets from multi-site clinical trials with strict data integrity requirements.
Drug Traceability
Tracking pharmaceutical products through the entire supply chain from manufacturing to patient delivery.
Adverse Event Reporting
Capturing, analyzing, and reporting adverse drug reactions within strict regulatory timelines.
Data Integrity (ALCOA+)
Ensuring all data is Attributable, Legible, Contemporaneous, Original, and Accurate throughout its lifecycle.
Multi-Site Coordination
Coordinating clinical trials, manufacturing, and quality processes across global sites and time zones.
Our Solutions
Validated LIMS Platform
Laboratory information management with complete audit trails, e-signatures, and 21 CFR Part 11 compliance.
eClinical Trial Suite
EDC, ePRO, and CTMS modules for managing clinical trials from protocol design to database lock.
Pharmacovigilance System
Automated adverse event detection, MedDRA coding, and regulatory submission workflows for safety reporting.
Supply Chain Track & Trace
Serialization and aggregation tracking with DSCSA compliance for the pharmaceutical supply chain.
Quality Management System
Digital CAPA, deviation management, and change control workflows with automated escalation.
How We Deliver Results
Requirements & Risk Assessment
Formal requirements gathering with risk analysis following ICH Q9 guidelines for quality risk management.
Design Qualification (DQ)
Documented design specifications verified against user requirements and regulatory standards.
Validated Development
Code development with unit testing, code reviews, and traceability matrices linking requirements to tests.
IQ/OQ/PQ Validation
Installation, operational, and performance qualification testing with formal validation protocols.
Regulatory Submission Support
Providing validation documentation packages and supporting regulatory audit processes.
What We Take Care Of
21 CFR Part 11 Compliance
Electronic signatures, audit trails, and access controls meeting FDA requirements for electronic records.
Data Integrity (ALCOA+)
System design ensuring all data meets ALCOA+ principles with complete traceability.
GxP Validation
Full IQ/OQ/PQ validation lifecycle with documented evidence for regulatory inspections.
Disaster Recovery
Validated backup and recovery procedures with documented RPO/RTO and regular testing.
Why Choose Us
Our team includes engineers with GxP experience and understanding of pharmaceutical regulatory requirements. We've built validated systems for CROs, biotech firms, and pharmaceutical manufacturers that have passed FDA and EMA audits without findings.
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