Our Services
We provide GMP consulting and quality assurance services across the full scope of FDA-regulated manufacturing. Every engagement is tailored to your operation, your products, and your compliance goals.
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
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 batch records to sanitation programs, we set up the systems your team needs to operate with confidence.
- Custom SOP development for your operation
- Quality management system design and setup
- Batch record and documentation templates
- Staff training on new systems and procedures
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
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
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
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
Organic Certifications for Manufacturing Sites and Brands
We guide manufacturers and brands through the organic certification process, including USDA National Organic Program (NOP) compliance for production facilities. 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
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
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
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