Quality &
Regulatory Services
Quality & Regulatory Services
FiunEx delivers assurance of Regulatory and Quality Compliance for Healthier, Safer Devices, Diagnostics, Medication and Cosmetics
Services
Digital Compliance
Ensuring Digital Solution Compliance
GDPR and Data Privacy
EIFU Electronic Instructions for Use
Record Management & Digital Signatures
IT Security ISO 27001
Supply Compliance
Trade Compliance support
Good Distribution Practice GDP
Transport Validation
Track & Trace Solutions
Cold Chain Compliance
Ensuring End-to-End Supply Chain Compliance
Regulatory Affairs
Projects with regulatory bodies.
Non-Conformance Management
Regulatory Dossier Remediation
Global Regulatory Expertise, USA FDA, IVDR, MDR, GMP
Software as a Medical Device
Ensuring Compliance to Regulations
Validation
Agile, Digital and tandard Validation Approaches
Process & Transport Validation
Method & Cleaning Validation
CSV, Enterprise Resource Planning (Coordination and Support)
Product Validation
Continuous Rolling Product Validation
Validation as a Service
Manufacturing Compliance
Ensuring Production Environment Compliance
Quality Engineering
Optimized Product Quality
Industry 4.0 / Manufacturing 4.0
Manufacturing Execution Systems
Process Automation
Validation of Distributed Control Systems
CSV, IQ, OQ, PQ
Validation as a Service
Laboratory & Quality Control
Laboratory & Quality Control
Ensuring Compliance in Laboratory Environment
LIMS / ELN Controlled Implementation & Support
Lean optimization and Six Sigma
Technical Writing Support
Product Verification
Design Transfer
Laboratory to Manufacturing Scale-up
EHS and Biosafety
Compliance Project Management
Ensuring accurate delivery of services in first go
R•QMS: ISO 9001, ISO 13485 (Implementation management, Audits etc.)
Project Quality Management
Leading Programs to Project and Beyond
Due diligence, Mergers & Acquisitions
Risk Management
Risk Management ISO 14971, ICH 9
Risk Management Remediation
Safety Assurance Case
Reliability Analysis
Failure Analysis
Correct application of Risk Management Methodologies
Risk Analysis
Hazard Analysis
Ensuring Safe Compliant Products
Quality Management
Ensuring Organizational, Production and Service Consistency
Auditing Services include ensuring Audit Readiness- Supplier, Third Party, Internal
PRRC Support
Non-Conformance Management: Deviations and CAPAs
Quality Management System Remediation
Complaint Management, Post Market Surveillance etc.
Qualification
Agile, Digital and Standard Qualification Approaches
Line, Equipment & Instrument Qualification
Clean Room Qualification
Technology Transfer
Facilities and Machinary Qualification
case studies
case 1
Conversion of Research Use Products to IVD (Class 1 & 2) for a bacteriology / virology diagnostic standards company across the globe. Company with revenue of over $60M with growth of 40% is headquartered in US
case 2
510k for diagnostic IVD assay for $60M company
case 3
Post Market Surveillance for Organic Standards $120M company
case 4
QMS standardization across 4 sites for a Medical Device company
case 5
Remediation efforts post FDA Audit for Water Analysis Medical Device for $1.5B organization