Our Services

The T-TRACS Regulatory Roadmap-Your Path to Full Compliance

Achieving GLP compliance is a marathon, not a sprint. We provide a structured, five-phase roadmap designed to transition your facility from its current state to a position of audit-readiness and global recognition.

Every journey begins with a baseline. We conduct an exhaustive on-site audit of your current facilities, equipment, personnel training, and documentation practices. We identify "compliance debt" and provide a prioritized risk-assessment report.

Based on the gaps identified, we architect a custom Quality Management System (QMS). This includes drafting or refining your Standard Operating Procedures (SOPs), establishing a secure data archiving system, and defining the roles of the Quality Assurance (QA) unit.

A system is only as good as the people running it. During this phase, we conduct hands-on training for your Study Directors, Principal Investigators, and technicians. We ensure everyone understands the nuances of data recording, sample handling, and the "Attributable, Legible, Contemporaneous, Original, and Accurate" (ALCOA+) principles.

To ensure you are ready for the real thing, T-TRACS performs a rigorous "Mock Inspection" that simulates a visit from a national monitoring authority. We stress-test your systems, audit your raw data and reports, and coach your team on how to interface with inspectors.

GLP is a state of being, not a one-time event. We provide ongoing QA support, periodic internal audits, and updates on evolving OECD/FDA guidelines to ensure you never lose your compliant status.
Why Our Leadership is Your Strategic Advantage

In the world of GLP, the "Who" matters as much as the "How." With T-TRACS, you are not just getting a consultant; you are getting:


"Refusal to File" Risk: We catch technical errors that generalist firms often overlook.

Inspector-Level Foresight and Strategic Foresight: We identify gaps the way a government auditor would, before they visit your site. We anticipate the "next question" an inspector might ask, drawing on our team's experience as former Lead Inspectors.

Global Harmonization: We ensure your data is prepared in a way that is acceptable across multiple jurisdictions simultaneously, saving you time and capital.

Governmental Credibility: Our partners have spent years shaping and enforcing the standards they now help you achieve.

Case Study

Transforming a Mid-Sized Laboratory for Global Submission

The Challenge

A mid-sized agrochemical laboratory was struggling with inconsistent data recording and a lack of a formalized Quality Assurance unit. Their goal was to submit a safety dossier to the EPA (US) and ECHA (EU), but they lacked the GLP certification required for their data to be accepted internationally.

The T-TRACS Solution

T-TRACS was brought in to overhaul its compliance framework.

  • Action: We redesigned their sample tracking system and implemented a digital audit trail for their analytical instruments.
  • Action: We trained a dedicated team to function as an independent QA unit, providing the necessary "eyes and ears" for management.
  • Action: Over six months, we supervised three pilot studies to ensure the new SOPs were practical and consistently followed.

The Result
  • Certification: The laboratory successfully passed its first official inspection by the National GLP Monitoring Authority with zero major findings.
  • Global Reach: The resulting data was accepted by both US and EU authorities without the need for supplemental studies.
  • ROI: By avoiding study rejection and re-testing, the client saved an estimated $450,000 in operational costs and accelerated their market entry by 14 months.

The T-TRACS Service Matrix: End-to-End Regulatory Solutions

Our expertise spans the entire lifecycle of a product, from the initial setup of a laboratory to the final submission of global regulatory dossiers.The table below outlines how our Domain Experts support your specific needs.

Service Category Target Sectors Specific Solutions & Deliverables Lead Domain Expert
GLP System Setup Pharma, Biotech, Agrochemicals Design of QMS, SOP drafting, Facility Layout review, and Facility establishment. QA & System Specialists
Pre-Clinical Guidance Pharma, Medical Devices Study design for Toxicology & Safety Pharmacology; Dose-response analysis, etc. Toxicology Experts
Gap Analysis & Audits All GLP-regulated Laboratories Comprehensive readiness audits, Mock Inspections, and CAPA (Corrective Action) plans, etc. Former Lead Inspectors
Data Integrity Review Analytical & Environmental Labs Software validation (21 CFR Part 11), ALCOA+ audit trail reviews, and raw data archiving, etc. Former Lead Inspectors and Digital Compliance Experts
Regulatory Submissions Global Manufacturers Dossier preparation for IND, NDA, BLA (FDA/ EMA), and Agrochemical registration (CIB-RC, EPA/ ECHA). Regulatory Strategists
Chemical & Agrochemical Ecotoxicology data evaluation, Environmental Fate studies, and REACH compliance. Environmental Scientists Environmental Safety
Training & Coaching All Research Organizations Personnel training on GLP principles, Study Director responsibilities, and Audit hosting. Training Coordinators and Former Lead Inspectors

How to Use This Matrix

If you are a New Facility:

Look at GLP System Setup and Training. We help you build the foundation from the ground up to ensure a "first-time" pass during inspection.

If you have an Upcoming Submission:

Focus on Regulatory Submissions and Data Integrity. We act as a final "filter" to ensure your dossier is bulletproof before it reaches a regulator's desk.

If you are facing an Audit:

Immediately engage our Gap Analysis & Audits team. Our former Lead Inspectors will identify vulnerabilities and help you resolve them before the official visit.

What Happens Next?

To ensure T-TRACS provides a proposal that is both technically accurate and commercially viable, we follow a strict onboarding protocol.

1. Expert Review

Your inquiry will be assigned to a lead promoter/expert, based on the domain expertise required.

2. Discovery Call

We will schedule a brief technical call to clarify the scope and specific regulatory hurdles.

3. Bespoke Proposal

Within 3-5 business days, you will receive a detailed proposal including a timeline, milestones, and a clear breakdown of deliverables. [cite: 213]

Request a Specialized Quote

Frequently Asked Questions

Navigating the Regulatory Landscape

While both focus on quality, ISO 17025 is a laboratory management standard primarily for testing and calibration. GLP is a regulatory requirement for non-clinical safety studies intended for submission to government authorities. T-TRACS specializes in harmonizing these two frameworks for labs that require both.

Depending on the current state of infrastructure and documentation, the process usually takes 6 to 12 months. This includes gap analysis, SOP drafting, staff training, and conducting "pilot studies" to test the system.

Most firms use a generic checklist. Because our partners are Former Lead Inspectors for the NGCMA, we understand the "hidden" expectations of regulators. We don't just tell you whether a rule exists; we tell you how it will be interpreted during a high-pressure inspection.

Absolutely. Data integrity is the #1 reason for audit failure today. We assist in the validation of computerized systems, ensuring your electronic records are as defensible and permanent as paper ones.

Yes. We specialize in "Crisis Recovery." We help you draft a robust Corrective and Preventive Action (CAPA) plan and work with your team to remediate findings rapidly, helping you protect your facility’s certification status.

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