Transform Your Manufacturing Compliance
Helping manufacturers meet FDA, ISO, GMP, and global standards through smart compliance, audits, and scalable quality sys
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Our Mission
Our Mission
Our Mission
At 1st M Consulting, our mission is to empower small to mid-sized manufacturers in the medical device, Over the counter drugs, dietary supplement, and cosmetic industries to navigate complex regulatory landscapes with confidence. We are committed to helping clients establish structured, scalable, and compliant operations by aligning with FDA (21 CFR), ISO 13485, ISO 9001, GMP, and international quality standards. Through hands-on training, expert consulting, and audit preparation, we enable companies to meet regulatory expectations, reduce risk, and build long-term operational success. Our mission is not only about compliance—it's about building organizations that operate with integrity, efficiency, and measurable results.
Our Vision
Our Mission
Our Mission
Our vision is to be the premier regulatory compliance and quality systems partner for manufacturers seeking sustainable growth and global market access. We envision a future where compliance is no longer a burden but a strategic advantage—fueling innovation, trust, and long-term profitability. By continuously adapting to evolving global standards and harmonization initiatives, such as QMSR and MDR, we aim to lead the way in transforming regulatory requirements into business-building opportunities. Through our commitment to excellence, integrity, and client success, we aspire to help companies operate with confidence—every audit, every product, every time.
Our Value
Our Mission
Our Value
- Integrity – We uphold honesty and transparency in every aspect of our work.
- Excellence – We strive for the highest quality in compliance, documentation, and client service.
- Accountability – We take responsibility for delivering reliable, audit-ready solutions.
- Collaboration – We work closely with clients to build strong, long-term partnerships.
- Innovation – We stay ahead of regulatory changes to provide smart, forward-thinking solutions.
About 1st M Consulting
About Us
1st M Consulting helps small to mid-sized manufacturers meet FDA, ISO, GMP, and global compliance standards. With over 35 years of experience, we specialize in quality systems, audit readiness, and regulatory guidance for medical devices, Pharmaceutical, supplements, and cosmetics. We empower clients to build scalable, profitable, and inspection-ready operations through structured documentation, staff training, and strategic support.
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Operations Consulting
At 1st M Consulting, we measure our success by yours. Every strategy, system, and solution we provide is designed to help you grow with confidence, pass audits with ease, and operate with excellence. Whether you're launching a product or expanding globally, your success drives everything we do. We proudly partner with manufacturers who prioritize patient safety above all else.