About

TRUENORTH Compliance and Operations

TrueNorth Compliance and Operations was founded to help regulated manufacturing environments, including nutraceutical, pharmaceutical, and emerging regulated industries, on GMP-aligned compliance and operations support. We partner with companies so that they can operate with clarity, confidence, and consistency in highly regulated environments.

Manufacturing excellence doesn’t happen by accident. It requires clear processes, accurate documentation, trained teams, and practical GMP execution. That’s where TrueNorth comes in.

With hands-on experience across technician, senior technician, quality, compliance, supervisory, and management roles, TrueNorth brings a real-world, operations-first approach to compliance and manufacturing support. We understand how decisions on the floor impact quality, timelines, audits, and business outcomes—because we’ve lived it.

Our Approach

TrueNorth Compliance and Operations bridges the gap between compliance theory and operational reality.

We don’t deliver generic templates or abstract recommendations. We work alongside your team to:

  • Build documentation that reflects how work is actually performed

  • Train personnel in a way that sticks

  • Strengthen GMP systems without slowing production

  • Prepare your operation for audits, inspections, and growth

Our work is designed to be practical, scalable, and audit-ready.

Who We Serve

We support organizations across the manufacturing lifecycle, including:

  • Nutraceutical and dietary supplement manufacturers

  • Pharmaceutical and OTC manufacturers

  • Contract manufacturers (CMOs / CDMOs)

  • Growing startups preparing to scale

  • Established facilities preparing for inspections

Whether you need short-term support or longer-term operational guidance, TrueNorth adapts to your needs.

Why TrueNorth

Clients choose TrueNorth Compliance and Operations because we provide:

  • Hands-on manufacturing experience — not just advisory theory

  • Clear, usable documentation built for real operations

  • Straightforward communication with leadership and production teams

  • Reliable delivery aligned to timelines and regulatory expectations

We don’t just tell you what needs to change. We help you implement it.

Our Commitment

At TrueNorth Compliance and Operations, our commitment is simple:

Excellence In Every Operation.

Our Services

TrueNorth Compliance and Operations provides practical, results-driven consulting services designed to strengthen compliance, streamline operations, and prepare manufacturing teams for long-term success.

Services are available as hourly consulting or fixed-scope project engagements, depending on your needs.

Operations & Compliance Consulting

Ongoing advisory support for manufacturing and quality teams

Services include:

  • GMP guidance and decision support

  • SOP review and improvement

  • Batch record troubleshooting

  • Deviation and CAPA support

  • Supervisor and leadership coaching

  • On-call operational consulting

SOP Development & Remediation

Clear, audit-ready documentation built for real-world use

We develop and remediate SOPs that align regulatory expectations with actual manufacturing practices.

Services include:

  • SOP creation and revision

  • Documentation structure and formatting

  • Workflow alignment

  • Training integration

Project-based packages available

Batch Record Review & Remediation

Accurate documentation that tells the right story

We review, correct, and standardize batch records to ensure compliance, consistency, and inspection readiness.

Services include:

  • Single-product batch record cleanup

  • Multi-product or system-level remediation

  • Template standardization

  • Error trend identification

GMP Training Programs

Training that builds confidence and compliance

Our GMP training programs are tailored to the roles and responsibilities of your team.

Programs include:

  • Technician GMP training

  • Supervisor and lead training

  • Documentation and decision-making workshops

  • Custom facility-specific training

Available on-site or virtually.

Audit & Inspection Readiness

Preparation that reduces risk and surprises

We help facilities prepare for FDA, third-party, and customer audits with confidence.

Services include:

  • Documentation gap assessments

  • Mock inspections

  • Findings and corrective action roadmaps

  • Pre- and post-audit support

Startup & Scale-Up Support

Operational guidance for growing manufacturers

For new or expanding facilities, we provide support across:

  • Manufacturing readiness

  • Documentation systems

  • Hiring and training frameworks

  • Production flow and scalability

Available as hourly consulting or fixed-scope projects.

How We Work

  1. Initial Consultation – Understand your needs and objectives

  2. Defined Scope – Clear deliverables, timelines, and pricing

  3. Execution – Hands-on support and collaboration

  4. Closeout & Support – Final documentation and recommendations

Ready to Get Started?

If your operation needs clearer processes, stronger compliance, or experienced support during a critical phase, TrueNorth Compliance and Operations can help.

Excellence In Every Operation