We Are Quality - Services

We offer a wide range of services
specific to highly technical industries.

N

Planning & Assessment

  • GAP Analysis
  • Remediation Plans
  • Risk Management Assessments
  • Strategic Planning
  • Project Timelines Development
  • Project Management
Z

Improvements

  • Lean Manufacturing Projects
  • Six Sigma Principles
  • Quality Risk Management Approach
  • Quality Systems
  • Manufacturing Processes

Implementation

  • Validations / Technology Transfer
  • Remediation Plans
  • Equipment Commissioning
  • Equipment Decommissioning
  • Equipment Qualification (IQ/OQ/PQ)and Automation

Analytical Laboratory Support

Specialized analysis of lab processes and results

  • Data Review
  • Laboratory Investigation
  • Environmental Monitoring Support

Manufacturing Support

Critical processes support for technical industries

  • Shop Floor Support
  • Startup Support
  • Documentation Review
  • Manufacturing Controls
  • Business & Quality Metrics Design and Monitoring
i

Documentation Management

  • Document Control
  • Lifecycle Documentation
  • Document Retention
  • Document Archiving
  • Control Security Documentation

Training

  • On-Site and Off-Site Training
  • Technical Training
  • On the Job Training
  • Train the Trainers Certifications
  • New Hire Trainings

Engineering Control Support

  • Equipment Calibrations
  • Equipments Preventive Maintenance
  • Equipment Inventory
  • Equipment Qualification

Regulatory Affairs Support

  • NDA Documentation
  • NDA Filings & Post Approval Changes
  • PAI Readiness
  • CMC Sections

Quality Audit Management

  • Audit Preparation
  • Audit & GMP Inspections
  • Audit Response
  • Annual Product Reviews
  • Annual Product Reports
Z

Quality Systems

  • APR’s
  • Change Controls
  • Investigations
  • Complaints
  • Out of Tolerance
  • SOP Revision
  • Quality Metrics Design and Monitoring
N

Validation

  • Re-validation
  • Re-qualification
  • Cleaning Validations
  • Process Improvements
  • Equipment Qualification

Components Specifications

For Products, Raw Materials and Packaging

  • Review, Management and Control

Environmental Health & Safety

  • OSHA
  • Disaster Recovery Plan
  • MSDS

Get In touCh

Get a Free Estimate or Schedule an Appointment

QUALITY OPERATIONS SERVICES

Risk Assessment, APR’s, Change Controls, Investigations, Product Quality complaints, Project Management and more.

VALIDATION SERVICES

Technology Transfers, Manufacturing Controls, Process and Cleaning Validations, Equipment Qualifications (IQ/OQ/PQ).

REGULATORY COMPLIANCE

NDA documentation, Filings and Post Approval Changes. PAI Readiness, Audit Management and Audit Response & Monitoring.

FACILITIES / UTILITIES

Environmental Health & Safety, Water Systems, Corrective and Preventive Maintenance Support, Equipment Inventory are some of the Facilities and Utilities services we offer.

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