FDA Regulatory Compliance
About MLKC Consulting, LLC
Our Mission
Our Approach
Our Mission
At MLKC Consulting LLC, our mission is to empower businesses to achieve their full potential. We provide tailored consulting services that drive growth, efficiency, and innovation in a rapidly changing market
Our Team
Our Approach
Our Mission
Our team consists of experienced consultants with diverse backgrounds in various industries. We combine our expertise to deliver innovative solutions to our clients.
Our Approach
Our Approach
Our Approach
We believe in a collaborative approach to consulting, where we work closely with our clients to understand their needs and develop solutions together. Our goal is to build long-lasting relationships with our clients.
What We Do
Company Objectives
Ensure Regulatory Compliance & Readiness
- Provide expert guidance to help clients achieve and maintain compliance with FDA, ISO, and other regulatory requirements.
- Conduct comprehensive audits, gap assessments, and regulatory strategy development.
Promote a Culture of Quality & Continuous Improvement
- Support organizations in fostering a proactive quality mindset that extends beyond compliance.
- Implement best practices for quality management systems, risk mitigation, and data integrity.
Deliver Client-Centered Solutions
- Customize consulting services, training programs, and compliance strategies to address the unique needs of each client.
- Build long-term partnerships that prioritize client success and sustainability.
Enhance Operational Efficiency & Risk Management
- Optimize processes related to manufacturing, testing, labeling, and distribution to improve efficiency and minimize compliance risks.
- Provide corrective and preventive action (CAPA) solutions to address and prevent regulatory issues.
Stay Ahead of Industry Trends & Innovations
- Continuously update expertise on evolving regulatory expectations and industry best practices.
- Offer forward-thinking solutions that help clients adapt to changing market demands and compliance challenges.
Our Expertise
We are experienced in Medical Device, Pharmaceuticals, Blood Banking, Plasma Donation, Birth Tissue, Tissue Donation, Cosmetics, Combination products, Dietary Supplements and Animal Health Products.
We are well versed in ISO 9001 and ISO 13485.
Our specialties include but are not limited to Label Review; FDA 483/ Consent Decree/ Warning Letter response and follow up audits; Deviation Management; RCA and CAPA; Gap assessments; Site Inspections; Good Laboratory Practices; Document Control; Complaint and Recall Management; Supplier Quality Audits; FDA Establishment Registrations; Employee Training; and Board of Pharmacy Licensing.
We have working knowledge of regulations from the manufacturing, testing, labeling, and distribution perspective.
Quality Systems Consulting; FDA Expert
Our Experience
Our Expertise
At MLKC Consulting, LLC, we provide specialized regulatory and quality consulting for FDA-regulated industries, including pharmaceuticals, medical devices, blood and tissue banking, dietary supplements, and more. Our expertise spans FDA compliance, ISO 9001/13485, internal audits, supplier management, CAPA, recall management, and data integrity (21 CFR Part 11). With hands-on industry experience, we deliver tailored solutions to ensure compliance, optimize quality systems, and enhance regulatory readiness.
Talk with us today to establish how we can support your quality and compliance needs and put you on a solid track to success and profit.
Our Mission
At MLKC Consulting, LLC, we are dedicated to guiding businesses in FDA-regulated industries toward excellence in compliance, quality, and operational efficiency. Through expert consulting, tailored training, and proactive strategies, we empower our clients to navigate complex regulatory landscapes with confidence. Our commitment to integrity, innovation, and client success ensures that organizations not only meet compliance requirements but also build a sustainable culture of quality and continuous improvement
Why Us?
Clients choose MLKC Consulting, LLC for our deep regulatory expertise, tailored compliance solutions, and commitment to long-term success in FDA-regulated industries. We provide proactive strategies to mitigate risks, ensure compliance, and optimize quality systems, empowering businesses with practical, sustainable solutions. With integrity, transparency, and a client-centered approach, we help organizations stay ahead of regulatory challenges and achieve operational excellence.