Quality & Regulatory Network
Quality & Regulatory Network

Client Services

We're catalysts of positive business change, propelling companies ahead by enabling superior quality performance. Working with existing processes and focusing on targeted functional challenges, we help our clients respond to dynamic global change with insight and agility. 


In our constant endeavors to transform business to achieve a higher quality maturity level, the Quality & Regulatory Network provides a unique view by bringing the right mix of industry, process and technology to deliver measurable and sustaining business results.


Client Services Brochure

This brochure provides a brief overview of who we are and what we provide as consulting services.


Highlights of our Client Services can be found below. Don't see what you want? Please contact us so we can discuss your business needs.

Program Management

  • Enterprise Program / Project Management
  • Governance and Change Control
  • Business Analysis

Proactive Planning

  • Strategy & Roadmap Development
  • Risk Assessment and Planning
  • Success Measurements

Global Harmonization

  • Requirements Standardization Workshops
  • QMS Industry Surveys and Benchmarks
  • Change Management

Lean Quality

  • QMS Process / System / GMP Assessments
  • QMS Vendor Evaluations / Audits
  • Computer System Validation (CSV)
Data Integrity
  • Data Governance
  • Data Collection & Quality Planning
  • Data Monitoring / Compliance
  • Change Control

Operational Effectiveness

  • Quality Maturity Level Assessment
  • Batch/Lot Release Lifecycle Management
  • Supplier Quality Lifecycle Management

Patient Safety

  • Complaints Process / System Assessment
  • Patient Device Registry (Medical Devices)

Enterprise Visibility

  • Key KPIs and Metrics
  • Zero "Preventable Defects"
  • Internal and external
  • GMP, QSR and ISO
  • FDA's 483s, Warning Letters, ISO Audit Findings
  • Assist with Remediation including Gap Analysis, Internal Audits, Preparing Facility for FDA/ISO Inspection/Audit
  • GMP, QSR, iSO 9001:2015, ISO 13485:2016
  • Computer Systems Validation

Contact Us Today!

Quality & Regulatory Network LLC Greater Boston Area, MA

Email inquiry@qaranetwork.org


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