SErvices overview

Comprehensive Validation Solutions

Remote-First, Cost-Effective Support
Adris Pharma Services delivers expert validation through a remote-first model—reducing overhead while accelerating timelines. Seamlessly integrate with your internal engineering, quality, and compliance teams without the cost of full-time, on-site staff.
Agile, Risk-Based Validation
Our iterative, risk-based approach targets critical systems and regulatory priorities. This flexible model supports phased implementation and evolving compliance needs. All while ensuring data integrity and 21 CFR Part 11 compliance.
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 systems inspection-ready.
SOPs & Lifecycle Documentation Support
Develop, review, and refine validation SOPs, master plans, protocols, and procedures remotely—ensuring your documentation meets GxP expectations and your documentation is inspection-ready.

Supporting ACROSS the Pharma Lifecycle

Commissioning, Qualification & Validation (CQV)
Risk-based lifecycle validation protocol & report development of facilities, utilities, equipment, and processes (FAT/SAT, IQ/OQ/PQ, URS, VMP) following ASTM E2500 and GAMP5.
Computer System Validation (CSV)
Validation of manufacturing and automated systems (PWS, Lab equipment, BMS, EMS, Solvent Delivery Systems). Ensures compliance with 21 CFR Part 11 and EU Annex 11.

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: procedures, 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.

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.

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.