Welcome to Compliance Strategy Solutions
At Compliance Strategy Solutions, we guide dietary supplement companies through the complex landscape of FDA and GMP compliance with a focus on business enablement. Our team partners with clients to develop robust SOPs, ensure audit readiness, assess supporting tech stacks, and implement quality systems that scale. With ongoing regulatory support and strategic insight, you can focus on delivering high-quality products while we help keep your operations compliant, efficient, and growth-ready.
Features
SOP Development & Maintenance
We assist in creating and maintaining Standard Operating Procedures tailored to your specific operations, ensuring compliance with FDA regulations and GMP standards.
Audit Readiness & Certification
We prepare your organization for FDA, NSF, and third-party audits through comprehensive gap assessments, pre-certification reviews, and mock inspections—delivering clear, actionable insights to strengthen compliance and build confidence.
Quality System Consulting
We help you optimize quality systems and align with 21 CFR Part 111 and FDA expectations through tailored compliance programs, risk assessments, and regulatory strategies—supporting structured, documented processes and maintaining an audit-defense file.
Ongoing Regulatory Support
Our commitment to your success extends beyond initial compliance. We provide ongoing support through regulatory updates, personnel training, and periodic gap analyses to help your team stay current, prepared, and aligned with evolving GMP and FDA requirements.
About Compliance Strategy Solutions
A premier consulting firm dedicated to helping dietary supplement companies build strong, audit-ready quality systems and obtain compliance certifications. With decades of hands-on experience in GMP readiness, audits, SOP development, and regulatory alignment, we deliver tailored solutions that support FDA and GMP compliance, enhance operational consistency, and include pricing strategy and tech stack assessments—positioning clients for long-term success.
Our certified team brings decades of experience in compliance, business strategy, and operational optimization. We guide dietary supplement companies through FDA and GMP requirements with audit-ready solutions. Dawnette, a seasoned business strategist, aligns compliance with profitability. Rick, an ASQ member and chemist, drives quality, compliance, and operational efficiency through data-backed lab and hygiene insights.
Meet Our Team
Dawnette Wilt
Managing Director
Rick Greene
Quality Assurance Consultant
Consultant Collective
Project Consultants
Kimberly Baker
Audit Readiness Advisor
Frequently Asked Questions
What services does Compliance Strategy Solutions offer?
We help you build audit-ready quality systems by developing SOPs, quality and process controls, and practical documentation tools such as templates and logs. Our services align FDA regulations and GMP to support long-term compliance and certification.
How can I ensure my company is compliant with FDA regulations?
Our team can assist you in developing comprehensive Standard Operating Procedures (SOPs) and conducting regular audits to support that your operations meet FDA regulations and GMP standards.
What is the importance of cGMP compliance?
While the FDA sets the regulations (like 21 CFR Part 111 for supplements), cGMP defines how companies must operate to meet those standards. Think of the FDA as the rulemaker and cGMP as the operational blueprint to follow those rules. Being cGMP compliant shows that a company not only understands FDA expectations but also applies them effectively in daily operations.
How are Fees structured?
Our services are tailored to meet your organization's specific needs and objectives. We offer both bundled and unbundled service options, depending on your current compliance status and desired outcomes. Each project begins with a detailed Statement of Work (SOW) that outlines the scope, deliverables, timeline, and associated fees, ensuring transparency and alignment with your goals.
Let's talk!
Contact Us
Thank you for contacting us.We will get back to you as soon as possible.
Oops, there was an error sending your message.
Please try again later.
Please try again later.