What is a GMP gap assessment?

A GMP gap assessment evaluates your current manufacturing operations against FDA and industry GMP standards to identify compliance gaps. It covers documentation, processes, facilities, equipment, and personnel training, and results in a detailed report with prioritized findings and corrective action steps.

What is a GMP remediation program?

A GMP remediation program is a structured project to correct serious compliance gaps found in an audit, FDA 483, or warning letter. It includes root cause analysis, risk-prioritized corrective and preventive actions, rebuilding of affected systems and documentation, and effectiveness checks to confirm the fixes hold up on re-inspection.

Do you offer remote GMP consulting?

Yes. We offer both onsite and remote consulting for gap assessments, audits, process design, certification support, and GMP training programs. Remote sessions are conducted via live video with screen sharing and interactive Q&A.

What industries do you serve?

We serve five major FDA-regulated sectors: cosmetics (MoCRA compliance), dietary supplements (21 CFR Part 111), food (21 CFR Part 117), medical devices (QMSR, 21 CFR Part 820), and drugs/pharmaceuticals (21 CFR Parts 210 and 211).

Can you help prepare for FDA inspections?

Yes. We prepare your team for FDA inspections through mock audits, documentation review, staff training on investigator questions, and help you respond to warning letters or 483 observations.

Our Services

We provide GMP compliance, quality assurance, and quality control consulting services across the full scope of FDA-regulated manufacturing. Every engagement is tailored to your operation, your products, and your compliance goals.

Start at any step Understand

Remote and Onsite GMP Gap Assessments and Audits

We evaluate your current manufacturing operations against FDA and industry GMP standards to identify compliance gaps before they become problems. Our assessments cover documentation, processes, facilities, equipment, and personnel training. Whether conducted remotely or at your facility, each assessment results in a detailed report with prioritized findings and clear corrective action steps.

Full-scope facility and documentation review
Prioritized findings with risk classification
Root cause analysis for each identified gap
Corrective action plan with realistic timelines

Gap Assessments in Depth

Build

GMP Process Design and Implementation

Building a compliant operation starts with the right processes. We design and implement GMP-compliant workflows, standard operating procedures (SOPs), and quality management systems tailored to your specific products and production environment. From receiving of ingredients to making and shipping product out the door, we set up the simple systems your team needs to operate with ease and confidence.

Custom SOP development for your operation
Quality management system design and setup
Ingredient, raw material, and component specifications
Finished product specifications
Batch record and documentation templates
Staff training on new systems and procedures

Process Design in Depth

Regulatory Review and Compliance

Keeping up with FDA regulations, MoCRA requirements, 21 CFR standards, and state-level rules is a full-time job. We review your current compliance status, identify areas of risk, and develop strategies to bring your operation into full alignment. We also prepare your team for FDA inspections and help you respond to warning letters or 483 observations.

FDA, MoCRA, and 21 CFR compliance review
Inspection preparation and mock audits
Warning letter and 483 response support
Ongoing regulatory monitoring and updates

Inspection Readiness in Depth

Fix and verify

GMP Remediation Programs

When an audit, FDA 483, or warning letter exposes serious gaps, we build and run a GMP remediation program that turns findings into a completed, verifiable fix. We scope the work, prioritize by risk, rebuild the affected systems and documentation, and stay with you onsite or remotely through execution so your remediation project closes out and holds up on re-inspection.

Remediation planning scoped to 483 and warning letter findings
Risk-prioritized corrective and preventive action (CAPA)
System, process, and documentation rebuild
Effectiveness checks and re-inspection readiness

GMP Remediation in Depth

Testing Compliance

We review and verify that your testing protocols meet the requirements set by FDA, USP, and other applicable standards. This includes raw material testing, in-process testing, finished product testing, and stability studies. We make sure your lab operations and documentation hold up under regulatory scrutiny.

Raw material, in-process, and finished product testing review
Stability study protocol verification
Lab documentation and method validation audit
Protocol redesign and lab staff retraining

Testing Compliance in Depth

Supplier Audit Management

Your supply chain is only as strong as your weakest supplier. We develop and manage supplier qualification programs, conduct second-party audits of your vendors, and help you build a risk-based supplier monitoring system. Our audits assess GMP compliance, quality agreements, and material specifications to protect your products and your reputation.

Supplier qualification and approval programs
Second-party vendor audits
Risk-based monitoring systems
Corrective action procedures for underperforming suppliers

Supplier Audits in Depth

Certify

GMP Certification Support, Onsite and Remote

We prepare your facility for third-party GMP certification audits, including NSF, SQF, and other recognized schemes. Our support includes pre-audit readiness assessments, documentation preparation, staff training, and onsite guidance during the actual audit. We stay with you through the process until certification is achieved.

Pre-audit readiness assessments
Documentation preparation and review
Staff training and interview preparation
Onsite guidance during certification audits

Certification Support in Depth

Organic Certification Consulting

We guide manufacturers and brands through the organic certification process, including USDA National Organic Program (NOP) compliance for production facilities. Certification is granted by USDA-accredited certifying agents; we prepare you to succeed with them. Our support covers documentation, process adjustments, ingredient sourcing verification, and audit preparation to help you earn and maintain your organic certification.

USDA NOP compliance guidance
Ingredient sourcing and traceability verification
Process adjustment for organic production requirements
Audit preparation for organic certifying agents

Organic Certification in Depth

Scale and sustain

Onsite Engineering Support and Facility Design for GMP Compliance

We provide engineering-level guidance for facility layout, equipment selection, and process flow design to make sure your manufacturing space meets GMP requirements from the ground up. Whether you are building a new facility or retrofitting an existing one, we help you design spaces that support clean production, proper material flow, and regulatory compliance.

Facility layout and process flow design
Equipment selection and qualification support
Clean room and controlled environment planning
GMP compliance review for new and existing facilities

Facility Design in Depth

GMP Training Programs

We offer onsite and remote training packages for manufacturing teams at every level. From GMP fundamentals and documentation practices to internal audit training and FDA inspection readiness, our programs are built around your products, your processes, and your compliance needs.

Onsite and remote delivery options
Custom programs for your operation and product type
GMP fundamentals, documentation, sanitation, and audit training
FDA inspection readiness and industry-specific compliance

Explore Our GMP Training

Audit-ready, and it holds

Have Questions About a Specific Service?

Not sure where to start? Let us know and we will put you on the right path.

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