Values: Integrity; Flexibility; A Can Do Attitude
Hilliard, Ohio 43026, United States
What We Do
About the Owner
My name is Meredith Crabtree, Owner of MLKC Consulting.
I have over 30 years' experience with FDA including but not limited to FDA cGMP, GTP, GDP, GDocP, CLIA, AABB, AATB, ISO, DEA, and Board of Pharmacy/ VAWD regulations.
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
After 30 years in the industry, I decided to alter my direction. Now, I share my experiences by helping other establishments get into compliance or remain compliant with applicable regulations. Whether you are a start up company or have been established in the industry for years, MLKC Consulting is designed to help build stronger processes that meet regulations and standards but also keep the business objectives in mind. We use our skills and experiences in the industry to train and mentor clients to obtain the necessary understanding of the regulations and requirements expected in the field.
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, 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.
Why Us?
The Cost of Quality is a key aspect to any organization that must meet regulations and standards; however there is often lack of internal resources to either identify and/ or implement those needs. We save clients the time and energy required to manage resources throughout the duration of their contract