Industries We Serve

We work with companies navigating complex regulatory landscapes across multiple product categories. From FDA registration and compliance planning to state and international requirements, our team helps you understand what is expected and how to meet those expectations. We support clients dealing with 21 CFR regulations, MoCRA, and other federal and state mandates, and we can serve as your compliance partner during inspections, audits, and regulatory submissions.

• FDA registration and facility compliance
• 21 CFR regulatory guidance across product types
• Inspection preparation and response support
• Warning letter and 483 observation remediation

The cosmetics industry is under increasing regulatory pressure, especially with the Modernization of Cosmetics Regulation Act (MoCRA). We help cosmetics manufacturers and brands establish compliant GMP systems, proper product safety documentation, and facility registration with the FDA. Our team has worked with manufacturers producing everything from skincare and color cosmetics to personal care and hair care products.

• MoCRA compliance and facility registration
• Product safety substantiation and documentation
• GMP system setup for cosmetic manufacturing
• Label review and claims compliance

Dietary supplement manufacturers face strict FDA requirements under 21 CFR Part 111. We help supplement companies build quality systems that cover identity testing, in-process controls, label claims verification, and proper documentation. Whether you are a contract manufacturer or a brand with your own facility, we make sure your operation meets the standard. We also support companies preparing for third-party GMP certification audits from organizations like NSF and SQF.

• 21 CFR Part 111 compliance
• Identity testing and specification programs
• SOP development and staff training
• Third-party GMP certification readiness

Medical device manufacturers must comply with 21 CFR Part 820 (Quality System Regulation) and prepare for MDSAP audits and FDA inspections. We support device companies with quality management system development, design controls, risk management, and production process validation. Our team helps you build a quality system that satisfies both FDA requirements and international standards like ISO 13485.

• 21 CFR Part 820 and ISO 13485 compliance
• Design controls and risk management
• Process validation and equipment qualification
• MDSAP audit preparation

Pharmaceutical manufacturing requires compliance with 21 CFR Parts 210 and 211. We work with drug manufacturers on cGMP compliance, process validation, laboratory controls, and documentation systems. Our consultants help you maintain audit-ready operations and respond effectively to FDA findings. Whether you produce OTC products, prescription drugs, or active pharmaceutical ingredients, we bring the regulatory knowledge your team needs to stay in good standing.

• 21 CFR Parts 210 and 211 compliance
• Process validation and laboratory controls
• Batch record review and documentation systems
• FDA inspection readiness and response