Medical Device & Pharmaceutical Consulting Inc. consists of a team of consultants highly skilled in multiple aspects of regulatory and quality compliance for both the medical device and pharmaceutical industries. Wayner Williams, founder and president, holds a Bachelor of Science degree in Chemical Engineering, a Masters in Materials Science and Engineering, a Masters in Pharmacy and a certification in Drug Regulatory Affairs from the Department of Pharmaceutical Outcomes and Policy. While her engineering training provides her with the scientific skills necessary to meet the needs of her customers, her Masters in Pharmacy and her Drug Regulatory Affairs Certification provides her with the necessary tools to deliver on the regulatory aspects of drugs and medical devices essential for the global marketing of products including writing pre-market applications, labeling and risk management.
7749 Normandy Blvd.
Jacksonville, FL 32221
Extensive knowledge of the interconnection of quality system deliverables, including design control, risk management and product lifecycle management as well as her ability to deliver and execute these requirements have afforded her the opportunity to serve as company representative in multiple successful health authority audits including FDA, Japan’s MLHW, BSI and others.
Her knowledge and expertise includes:
New Product Introductions
Regulatory Submissions - 510(k), PMA, ND & aNDA Knowledge
Device, Pharmaceutical & Health Care Compliance Regulations
Quality System Regulations and Associated Documentation
Product Lifecycle Management (PLM)
Global Health Authority Liaison*
*FDA, BSI and Japanese MHLW
Wayner has also conducted many training and teaching engagements ranging from regulatory and quality system training to skills essential for success in new product development and other cross functional fields of interest.
Contact us today to see how we can help you manage your new product introductions, regulatory submissions and global quality system requirements.
Her formal training combined with over 23 years of experience in global medical device and pharmaceutical product development, regulatory affairs and quality system compliance, make Wayner an expert adviser in regulatory and compliance activities.
Wayner has worked within the Johnson and Johnson family of companies in multiple areas of accountability including formulation development, new product development, new product project management, developing and implementing quality systems, design control and implementing product lifecycle management systems which interconnect and render useable all of the data required to demonstrate quality system compliance to regulatory bodies. She has also worked with multiple device types and combination drug/device products for companies ranging from Fortune 500 to small startups.
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MD & PC Mission Statement:
Delivering compliant, audit ready quality system documents and solutions that support new product introductions, regulatory submissions and global quality system requirements for the medical device and pharmaceutical industries