
Adris Pharma Services-
Expert remote Pharmaceutical Consulting Services
Your Trusted Partner in Pharmaceutical Engineering & Systems
Compliance | GMP | Risk Assessment | Streamlined IOPQ
Adris
Pharma Services - at a glance
Remote Validation Expertise. Risk-Based Precision. GMP Compliance Delivered.
In today’s pharmaceutical landscape, businesses demand smart, scalable, and cost-effective validation—without compromising compliance. Adris Pharma Services delivers exactly that through remote-first model, iterative management and risk-based validation support that ensures audit readiness, GMP alignment, and operational efficiency across your equipment, utilities, computerized systems and quality systems.
SErvices overview
🛠️ Comprehensive Validation Solutions—Delivered Remotely
🌍 Remote Support That Reduces Costs, Not Quality
Adris Pharma Services operates with a remote-first model, allowing clients to tap into specialized validation expertise without the overhead of full-time, on-site resources. This approach supports faster timelines, lower costs, and seamless integration with internal engineering, quality, and compliance teams.
🔄 Iterative & Risk-Based Validation Management
Our risk-based, iterative approach ensures validation efforts focus on what matters most—critical systems, high-impact areas, and regulatory priorities. This agile methodology supports phased implementation, flexible resource planning, and compliance that evolves with your business needs.
🚀 Streamlined IOPQ Execution
From new installations to legacy system requalification, Adris develops and executes Installation (IQ), Operational (OQ), and Performance Qualification (PQ) protocols remotely—ensuring traceability, regulatory compliance, and minimal disruption to operations.
🔍GMP Gap Assessments & Remediation Planning
Adris performs remote GMP gap assessments, identifying compliance risks across systems, documentation, and procedures. Findings are translated into a clear, actionable remediation plan—closing gaps efficiently while keeping your teams inspection-ready.
💡 Computerized Systems Validation (CSV)
With deep experience in GAMP 5-aligned CSV, Adris remotely validates computerized systems (MES, LIMS, QMS, SCADA, etc.) for data integrity, 21 CFR Part 11 compliance, and secure digital operations. Remote process ensures speed without sacrificing accuracy or completeness.
📄 SOPs & Lifecycle Documentation Support
Develop, review, and refine validation SOPs, master plans, protocols, and procedures remotely—ensuring your documentation meets GxP expectations and reflects current operations. Adris ensures your documentation is inspection-ready, every time.
Supporting ACROSS the Pharma Lifecycle
System Validation Services
Commissioning, Qualification & Validation (CQV)
Risk-based lifecycle validation of facilities, utilities, equipment, and processes (FAT/SAT, IQ/OQ/PQ) following ASTM E2500 and GAMP5.Computer System Validation (CSV)
Validation of manufacturing, lab, and quality systems, including ERP, MES, LIMS, SCADA, and PLCs. Ensures compliance with 21 CFR Part 11 and EU Annex 11.
GMP Compliance & Quality System Support
Gap Assessments & Audit Preparation
Facility and documentation readiness reviews for GMP inspections (FDA, EMA, WHO, MHRA). Includes mock audits and CAPA planning.Quality System Implementation
Design and optimization of compliant quality systems: change control, deviation management, CAPA, training, and document control.Risk Management
Application of ICH Q9 risk-based principles across validation, qualification, and quality assurance activities.Data Integrity Compliance
Assessments and remediation plans to align with ALCOA+ principles and regulatory expectations for electronic records and signatures.
Technical Compliance Consulting
URS & Protocol Development
Authoring of user requirement specifications, validation master plans, protocols, and reports in alignment with regulatory and operational needs.Deviation & Investigation Support
Technical root cause analysis (5 Whys, Fishbone, FMEA) and support in writing compliant deviations and CAPAs.Regulatory Documentation Review
Independent review of validation documentation, quality records, and SOPs to ensure completeness, accuracy, and inspection readiness.
Why Remote Validation Is the Smarter Choice
⚙️ Cost-Effective Expertise
Avoid the cost of full-time or on-site consultants. Access specialized validation support when and where you need it.⚙️ Faster Project Delivery
Remote collaboration allows faster document turnaround, flexible scheduling, and minimized project downtime.📄 Always Audit-Ready
All deliverables meet GMP, FDA, and Annex 11 requirements—backed by real-world audit experience.
Need Expert Validation Support?
Let’s Connect
Whether you’re preparing for an audit, addressing compliance gaps, or validating new systems, Adris Pharma Services provides expert, remote-first validation support tailored to your business needs.
Contact Information
Email
info@adrispharma.com
Phone
+1 (305) 542-9477
Location
Adris Pharma Services (Remote Office)
Based in Miami, Florida USA
🔐 Confidentiality
Adris Pharma Services is happy to provide a Mutual Non-Disclosure Agreement (NDA) upon request prior to any project discussions.