FDA REGULATION CONSULTING SERVICES
QMR, LLC provides Quality Management and Regulatory Consulting Services including for ISO 9000/13485, FDA Compliance Consulting, Product Submissions, FDA 483/Warning Letter Responses, Quality Assurance and Management, Quality Systems Certification, Training and Vendor Sourcing.
QMR, LLC is recognized as FDA compliance and regulatory affairs experts. We are also passionate about the consulting services we perform. Our aim is to help our clients comprehend the intent and the sanctions of both the FDC Act and 21 Code of Federal Regulations (CFR), in order to develop, implement, and maintain systems and procedures that are right for your business needs and meet specific regulation requirements. Our mission is to help our clients develop efficient and effective quality systems in order to commercialize safe and efficacious products, which consistently meet quality, customer, and regulatory requirements.
QUALITY MANAGEMENT & ASSURANCE IS KEY
We are experienced in all phases of the client firm’s product development strategy. We prepare quality regulatory submissions, build documentation systems and efficient customized procedures, and help accelerate the product development process. We prepare firms for FDA Inspections by performing mock FDA inspections and on-site training of an audit host team. Following any FDA inspection, we can expertly evaluate FDA-483 observations, coordinate, write, and review responses, and prepare Master Compliance Plans (MCP) in order to meet regulatory expectations and intercept any further regulatory action.
PROVIDE COST EFFECTIVE SERVICES
We operate in a cost-effective manner, because of our modest organizational structure. This enables us to provide you extremely competitive project proposals. Time is money when hiring consultants. Thereby, we can reduce costs based on our intimate knowledge of subject manner. Bringing over 25 years of experience we can help various FDA regulated firms meet their goals and objectives in a timely manner.
ARCHITECTS OF QUALITY SYSTEM BASED SOLUTIONS
FDA investigators utilize a system-based auditing strategy. Based on the inspectional findings and previous compliance history, the local District Office Compliance group determines a firm's state of compliance and recommends further action if warranted. In February 2001, the Center for Drug Evaluation and Research (CDER) adopted a system based inspection program [Compliance Program (CP7356.02)] for drug manufacturers. Device manufacturers are routinely inspected under the Quality System Inspection Technique (QSIT), which was introduced by the Center for Devices and Radiological Health (CDRH) in August 1999. This program focuses on inspecting key quality subsystems, starting and ending with Management Controls.
QMR is proficient in both the Quality System Regulations (QSR) for Medical Devices and the FDA Compliance Program for the Drug Industry. We have not only implemented effective quality systems for both start-ups and Fortune 500 companies, but we have also effectively redesigned out-dated or ineffectual systems through quality management and assurance programs. Solving quality systems problems are long-term solutions and save firms money and time in the short and long term.
LEADERS IN PROMOTING CLIENT AND CUSTOMER SATISFACTION
QMR serves the medical device, biopharmaceutical and pharmaceutical industries by providing excellent quality, regulatory, and compliance solutions and expertise. Our aim is to help you achieve your project goals and objectives, on time and within budget, while complying with the current appropriate regulations and requirements. We build excellent working relationships and help businesses achieve their objectives and goals.