Thriving in the life sciences industries requires more than being able to meet the increasing demands of the market. It also depends on maintaining compliance with the latest regulatory requirements across all levels of an organization.
With over 30 years of service as a compliance consulting firm, Maetrics has developed and executed pragmatic solutions for the majority of the world’s leading biotechnology, pharmaceutical, medical device, and diagnostic products organizations.
Quality, Compliance, & Regulatory Solutions from a Single Source
Our team takes a hands-on, collaborative approach to delivering strategies that allow organizations to develop proactive compliance plans and, if necessary, reactive remediation efforts on a global basis.
Through our tested and proven processes and methodologies, as well as our proprietary software, Maetrics provides the leadership necessary to direct effective compliance efforts and to drive processes and systems so they operate at an optimum level of quality, even within the most challenging environments.
Achieving Compliance While Balancing Business Goals
Product and delivery innovations can’t occur without a dynamic team dedicated to reaching new levels of scientific and engineering achievements. Innovations also won’t occur without a similar dedication to compliance and quality management techniques. Neglecting regulatory responsibilities will inevitably lead to delayed approvals, failed inspections, costly remediation efforts, potential financial penalties, and legal actions, as well as risking damage to a company’s reputation.
When partnering with Maetrics, our clients gain the advantage of our commitment to delivering regulatory compliance solutions that will provide a foundation of integrity, productivity, and quality for years to come. Our collective depth of skills enables us to provide a full range of consulting services, all of which are customized to individual needs and allow clients to be recognized in their industry for their focus on quality.
Have a question? Contact us today to learn more about Maetrics’ regulatory compliance strategies.
Third party support for MDR, IVRDR, MDSAP, ISO 13485, and Supplier Quality Audits can deliver value and objectivity across the whole review and implementation process.
Regulatory compliance requirements extend throughout the full product life cycle from development through approval, manufacturing, launch, and required post market reporting.
Quality Management Systems
In the life sciences industry, quality management is a multidimensional issue, covering more than just verification that a finished product meets certain expectations.
Long before any pharmaceuticals or medical devices reach the patients or the healthcare professionals who depend on them, the systems, equipment, processes, and methods behind developing, producing, and testing them must be validated to ensure they function as intended.
Today any life sciences enterprise inevitably faces ongoing risks to finances, products, data, equipment, property, and personnel.
Whether developing the latest healthcare breakthrough or producing established necessities that patients depend on, laboratory operations are at the heart of the life sciences industry.
Mergers & Acquisitions
The mergers occurring in the life sciences industry have generated an unprecedented amount of activity, resulting in hundreds of billions of dollars in transactions.
Across the life sciences industry, maintaining compliance is never a fixed destination. As new standards and regulations are issued, there is always more to learn, understand, and put into practice.
For life sciences organizations, staying up-to-date on changing and new regulations, the latest technologies, and the current best practices within the quality, compliance, and regulatory disciplines demands a continual process of evaluation.
As the nerve center of enterprise operations, a company’s IT systems must provide robust storage capacity, continuous uptime, and the ability to perform reliably for heavy amounts of user traffic.
ORGANIZATION CHANGE MANAGEMENT
In any industry, the organizations that are successful are those that can adapt to change. In today’s increasingly regulated environment, life sciences companies must proactively evaluate if their quality processes are evolving with industry demands.
Have a Question?
Contact us to learn more & find out how Maetrics can solve your regulatory or compliance issues.