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

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

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

Contact Us

No sales team, no pressure. Just an opportunity to see what we are all about.
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