SERVICES

MLKC Consulting has deep expertise in FDA Medical Device Regulations and the experience to guide your product from development to market. We provide comprehensive support, including:

• Regulatory Assessments
• Product Development Guidance
• Procedural Compliance & Documentation
• Device Testing & Validation
• Quality Control & Risk Management Systems

Our team ensures your product meets FDA, ISO, and Quality & Risk Management System standards, helping you achieve compliance with confidence.

Our consulting services ensure your cosmetic and dietary supplement products comply with FDA regulations and federal standards, helping you navigate complex requirements with confidence.

We provide ingredient assessments to verify compliance with FDA guidelines and industry safety standards. Our label reviews ensure accurate claims, proper categorization, and adherence to labeling regulations, including those for color additives and allergens.

We assist with ingredient evaluations to confirm regulatory status, GRAS (Generally Recognized as Safe) determinations, and compliance with dietary supplement cGMPs. Our labeling review ensures correct structure/function claims, nutrition facts, and required disclaimers to meet FDA and FTC regulations.

With our expertise, you can confidently bring your products to market while avoiding regulatory pitfalls.

We have extensive experience in the Blood and Tissue industry, including Plasma, Birth Tissue, and Stem Cells, ensuring compliance with FDA, AABB, AATB, and other regulatory standards.

• Product & Equipment Validation – Ensuring your processes, equipment, and systems meet regulatory and operational requirements.
• Supplier & Testing Laboratory Assessments – Evaluating third-party providers to verify compliance with industry standards.
• On-Site Facility Inspections – Conducting comprehensive audits to assess adherence to all applicable regulations and best practices.

With our expertise, we help organizations maintain compliance, improve operational efficiency, and uphold the highest quality and safety standards in blood and tissue processing.s

We offer technical, regulatory consulting, and guidance services for the pharmaceutical industry, covering generic and new drug products, OTC medications, and monograph drugs.

• Regulatory Strategy & Compliance – Navigating FDA requirements for NDAs, ANDAs, OTC approvals, and monograph compliance.
• Product Development Support – Assisting with formulation, stability studies, and regulatory submissions.
• cGMP Compliance & Quality Systems – Ensuring adherence to manufacturing, testing, and labeling requirements.
• DEA Compliance

With our expertise, we help pharmaceutical companies bring products to market efficiently while maintaining full regulatory compliance.

 If your establishment has received an FDA 483 or Warning Letter, MLKC Consulting has the expertise to guide you through a thorough and effective response. We have extensive experience assisting medical device, dietary supplement, pharmaceutical, and biologics companies in addressing regulatory concerns and implementing corrective actions.

Beyond response assistance, we help prevent future regulatory issues by providing compliance training, mock inspections, and proactive gap assessments to ensure ongoing adherence to FDA requirements. Let us help you strengthen your quality systems and regulatory readiness.

No one likes to think about recalls, but when they happen, they can be time-consuming and costly. MLKC Consulting provides expert guidance to help you navigate the recall process efficiently while maintaining compliance with FDA requirements.

• Reporting the Recall to the FDA – Ensuring proper classification and regulatory submission.
• Drafting Recall Alerts & Consignee Letters – Communicating effectively with stakeholders.
• Managing FDA Effectiveness Checks – Ensuring compliance with FDA follow-ups.
• Conducting Investigations & Root Cause Analysis – Identifying the source of the issue.
• Developing a Recall Strategy – Creating a structured approach to minimize impact.

Beyond recall management, we help implement process controls and preventive actions to reduce the risk of future recalls, protecting your brand and ensuring regulatory readiness.

 Training is not just important—it’s mandatory in regulated industries. At MLKC Consulting, we provide customized, impactful training programs that equip all levels of your organization with the knowledge and tools needed to make quality-conscious and compliant decisions.

Whether you need in-depth training to address a CAPA or audit finding, refresher courses, or annual compliance training, we deliver engaging and educational sessions tailored to your needs.

✔ On-Site & Virtual Training – Flexible formats to fit your organization’s schedule.
✔ Customized Content – Training designed to address your specific regulatory challenges.

• Annual GMP Training – Ensuring ongoing compliance with FDA Good Manufacturing Practices.
• Label Review – Understanding regulatory requirements for accurate product labeling.
• Root Cause Analysis Training – Developing problem-solving techniques for effective CAPA implementation.
• How to Write Effective SOPs – Crafting clear, compliant, and actionable standard operating procedures.
• Aseptic Technique – Best practices for contamination control in sterile environments.
• Good Documentation Practices (GDP) – Ensuring accurate, compliant, and audit-ready records.
• Creating a Quality Culture – Embedding quality-driven behaviors across your organization.

With MLKC Consulting, your team receives practical, regulatory-compliant training designed to enhance skills, ensure compliance, and drive continuous improvement.

 At MLKC Consulting, we provide expert auditing services to help organizations take a proactive approach to quality assurance and regulatory compliance. Our audits offer critical insights into your facility’s operations, ensuring adherence to FDA regulations, GXP standards, and industry best practices. We also assist in evaluating current or potential suppliers, vendors, and contract manufacturers to mitigate risks and ensure quality standards are met.

• Regulatory Mock Audits – Preparing your facility for FDA inspections and regulatory reviews.
• Laboratory Audits – Ensuring compliance with GLP and GMP laboratory standards.
• Due Diligence Audits – Assessing compliance risks before acquisitions, partnerships, or investments.
• Contract Manufacturer & Vendor Audits – Evaluating third-party compliance with regulatory and quality requirements.
• GXP Gap Analysis Audits – Identifying deficiencies in Good Manufacturing, Laboratory, and Clinical Practices.
• GLP Audits – Verifying adherence to Good Laboratory Practice regulations.
• Contract Research Organization (CRO) Audits – Ensuring compliance in outsourced clinical research operations.

With MLKC Consulting, you gain a trusted partner to help you maintain regulatory readiness, improve operational efficiency, and strengthen supplier oversight.

 Building & Strengthening Quality Systems

With over 30 years of experience in quality management, MLKC Consulting specializes in helping organizations develop, improve, and maintain robust quality systems. We ensure your operations align with industry regulations, FDA requirements, and best practices, allowing for safe, compliant, and cost-effective manufacturing and distribution.

• Developing & Implementing Best Practice Plans – Establishing efficient, industry-compliant quality processes.
• Enhancing Policies & Procedures – Refining existing systems for improved clarity and compliance.
• Regulatory Interpretation & Compliance Support – Helping organizations understand and apply FDA and industry standards.
• Trend Analysis & Continuous Improvement – Identifying and addressing quality system deficiencies.
• Site Oversight & Internal Audits – Implementing internal audit programs, performance metrics, and quality objectives.
• Management Control Enhancement – Strengthening leadership oversight, reporting structures, and governance.
• Organizational Structure Optimization – Evaluating staffing, responsibilities, and competency of quality teams.

Our goal is to build quality into every aspect of your organization, ensuring compliance, efficiency, and long-term success in regulated industries.

With deep expertise in FDA and other regulated industries, MLKC Consulting provides comprehensive regulatory compliance services tailored to your business needs. We help clients design, implement, and sustain efficient and effective compliance processes that align with current regulations and industry best practices.

By actively monitoring regulatory changes and evolving industry standards, we ensure our clients stay ahead of compliance requirements, reducing risks and maintaining operational integrity. Our goal is to help organizations not only achieve compliance but sustain it through proactive strategies and continuous improvement.

 How and where you manufacture, store, distribute, and sell products directly impacts their efficacy, reliability, and safety. To ensure compliance, all aspects of the supply chain must meet specific licensing and registration requirements.

At MLKC Consulting, we provide expert guidance through the facility registration and product listing process, ensuring your operations align with FDA and state regulatory requirements.

• FDA Facility Registrations – Assisting with initial registration, renewals, and compliance verification.
• Product Registrations & Listings – Ensuring proper classification and submission for regulatory approval.
• Board of Pharmacy Licensing – Helping organizations obtain and maintain required state pharmacy licenses.

With our comprehensive support, we help businesses navigate the complex regulatory landscape, ensuring compliance, operational efficiency, and market access.
 

End-to-End Compliance: Ensuring Quality Across the Supply Chain

Regulatory compliance doesn’t begin or end with the manufacturer—it extends to suppliers, contract manufacturers, distributors, testing labs, and other key partners. Every entity involved in the supply chain must meet strict regulatory requirements to ensure that products remain effective, safe, and reliable.

Whether you are a manufacturer assessing suppliers and distributors or a distributor handling regulated products, MLKC Consulting provides expert evaluation of processes, operations, and compliance activities. We ensure that all stakeholders adhere to applicable regulations, industry best practices, and quality standards, helping you mitigate risks and maintain regulatory integrity across the supply chain.