Quality &
Regulatory Services

Quality & Regulatory Services


FiunEx delivers assurance of Regulatory and Quality Compliance for Healthier, Safer Devices, Diagnostics, Medication and Cosmetics



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


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


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.


Agile, Digital and Standard Qualification Approaches

Line, Equipment & Instrument Qualification

Clean Room Qualification

Technology Transfer

Facilities and Machinary Qualification

case studies

case studies