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.
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