Our Services

With decades of expertise, our team provides a full suite of Quality and Compliance services for every stage of the business operational life cycle.

Service Offerings

Personnel Qualification and Staffing

  • Organizational Chart Development and Review
  • Job Descriptions and On-Boarding Support
  • Development and Tracking of Key Performance Indicators (KPIs)
  • Risk Management Planning
  • Business Contingency Planning
  • Training Programs

Quality and Compliance Systems and GMP Management

  • Technical Project Management
  • HACCP and SQF / Food Safety Planning
  • Standard Operating Procedures (SOPs) Development
  • Change Control / Deviations / CAPA Investigations
  • Non-Conformance Resolution
  • Customer Complaints and Adverse Event Reporting
  • Document Management
  • Electronic Quality Management Systems
  • Environmental Monitoring Program Development
  • Cleaning Validation
  • Recall Plans

Production and Operations

  • Process Validation
  • Inventory Management Systems Setup
  • Preventative Maintenance Programs
  • Equipment Selection, Qualification, and Validation

Quality Programs

  • Supplier Qualification
  • Manufacturing Batch Records
  • Internal Audit Program
  • Packaging Batch Records

Laboratory and Testing

  • Laboratory Controls
  • Analytical Method Validation
  • Raw Material Testing and Controls
  • Out-Of-Specification and Out-Of-Trend
  • Stability Test Design

Results of implementing good manufacturing practices and quality systems:

The ability to secure a third-party certification to GMP or ISO Standards
Systems that meet and exceed any state or federal regulatory requirement
Tech transfer and scalable solutions that protect your bottom line
Metrics and KPIs that provide investors and senior managers with operational health indicators
Compliance systems that combine best practices from parallel industries
A robust Quality System that leaves auditors with peace of mind and the answers they need
Proactive identification of risks and trends BEFORE non-compliant events occur

Need More Information?

Complete the form below to receive our marketing brochure.

Or call us at (719) 602-4610
Oops! Something went wrong while submitting the form.