With the rise of federal regulations and scrutiny for the life science industry, there is now a greater awareness of the risks and weak links that have developed in the quality management parts of leading pharmaceutical organizations. Maetrics, a leading international life science regulatory and compliance consultancy, believes the pharmaceutical industry should consider improving the culture of quality to help safeguard patients and drive efficiency in their businesses and has published a white paper to open up dialogue in the industry on this important subject.
In particular, this latest guide from Maetrics looks at:
• Specific examples of how pharmaceutical companies are failing to meet regulatory requirements;
• The pressures social media is placing on the industry;
• The effect of mergers & acquisitions on the global pharmaceutical sector;
• The most common quality deficiencies;
• Suggestions for businesses to follow in order to mitigate risk and deliver high business efficiencies.
To download the whitepaper and find out how Maetrics can help you adhere to the highest CGMP standards, implement a realistic and actionable auditing strategy and address risk in in order to continually grow your business, click here.
[more]Maetrics, the global consultancy firm that provides regulatory, quality, and compliance solutions to the life sciences sector, has published a free step-by-step whitepaper to help manufacturers understand the imminent changes and how to comply with the new IVDR that repeals Directive 98/79/EC as well as Commission Decision 2010/227/EU. To get a real handle on the major changes that the new IVDR brings and the practical implications for manufacturers and distributors of IVD products, click here.
[more]Maetrics, the global consultancy firm that provides regulatory, quality, and compliance solutions to the life sciences sector, today publishes new research quantifying the competitive advantage that medical device manufacturers can seize by moving quickly to comply with the new European Medical Device Regulation (MDR). Across the EU’s ten largest economies plus Switzerland, the Market Opportunity Value for compliance pioneers is estimated to be $16.469 billion. To read our research paper detailing the financial advantages of early adoption, click here.
[more]Maetrics, the global consultancy firm that provides regulatory, quality, and compliance solutions to the life sciences sector, will attend next month’s Medica trade fair in Düsseldorf (13-16 November 2017).
The company will exhibit on Stand F18-5, Hall 16 and will have senior executives available to share their experience and expertise in regulatory affairs in the medical devices sector. To coincide with the event, Maetrics will also launch a new research whitepaper on the European Medical Device Regulation (MDR), which officially came into effect in May this year and represents the single largest change to medical device regulations in Europe since CE Marking was introduced in 1993.
To schedule a consultation with Maetrics staff at Medica, click here.
[more]UK (September 04, 2017) – Maetrics, a global leader in life science consulting, has appointed Brian Moan to Director of Solutions Delivery in Europe. A highly qualified industry expert and thought leader specializing in Human Factors, Brian has been involved in MHRA working groups to develop industry guidance, has frequently presented around regulatory issues and has developed Medical Device presentations at Cranfield University as part of their MSc Program on Medical Devices.
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Peter Rose, Managing Director for Maetrics operations in Europe, will be speaking at the upcoming RAPS Regulatory Convergence about the new Medical Device Regulation (MDR) in Europe at the National Harbour at the DC Waterfront on Monday 11th September from 3:00PM to 3:45 PM.
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Indianapolis (6/15/17) Maetrics, a global management consulting firm providing life science companies with deep quality, compliance, regulatory solutions to the life sciences industry, recently named Chris Busse as Vice President, Business Development. In this role, Chris will be responsible for further developing our presence in the Western United States and managing key client relationships.
[more]Check out the press release Maetrics just released: Maetrics unveils the current landscape of UDI in the USA and the substantial benefits of early compliance in latest free whitepaper.
[more]Indianapolis (5/4/2016) Theoris Group’s Maetrics Division was pleased to donate 50 laptops to Lawrence North High School. Located in Indianapolis, Lawrence North is a Four-Star School with over 2,300 students.
[more]Maetrics’ Senior Manager, Parminder Kalle, highlights the importance of understanding and correctly implementing PMS mechanisms for manufacturers wishing to introduce or maintain distribution of devices in markets with new postmarket requirements.
[more]Maetrics partners with the Association of British Healthcare Industries (ABHI) to host a highly informative seminar on “The ROI of good quality and compliance”. The aim of the seminar was to provide regulatory executives and leaders in the medical device industry a variety of viewpoints on how to successfully integrate quality management and corporate compliance in order to achieve the best Return On Investment (ROI).
[more]Maetrics, dedicated to guiding life sciences companies through the challenges related to quality, regulatory, and compliance, recently published its 2016 training courses and newly offered seminars in the UK. Maetrics’ seminars are aimed at C-level executives and directors to inform on topical quality and regulatory issues to ensure their business can appropriately plan, budget, and be prepared for compliance in the ever changing regulated environment. Register online or view our complete 2016 brochure.
[more]Indianapolis (2/3/2016) Maetrics, a global management consulting firm providing life science companies with deep quality, compliance, and regulatory solutions, recently promoted Beth Crandall to the role of Managing Director. Ms. Crandall’s duties will expand to leading client engagement strategies and solutions as well as providing technical oversight on managing key client relationships.
[more]An FDA inspection can be nerve-wracking. As published in January’s edition of MDDI magazine (page 24), learn what Maetrics leader Norm Rabin advises you can do in person during an inspection to avoid receiving Form 483 observations or a warning letter.
[more]Indianapolis (1/14/2016) Maetrics, a global management consulting firm providing life science companies with deep quality, compliance, regulatory solutions, recently named Ed Roach as Managing Director. In this role, Mr. Roach will lead engagement strategies and solutions delivery for Maetrics clients as well as provide oversight to managing key client relationships.
[more](Boston, Massachusetts USA) About six months ago, the United States Food and Drug Administration (FDA) released new rules which require most medical devices distributed in the United States to bear a Unique Device Identification, or a UDI. Debara Reese, Vice President, Quality and Compliance, for global life sciences compliance consulting firm, Maetrics, recently spoke at the BioMed Conference in Boston where she explained, “The most common pitfall I’ve seen regarding UDI implementation is underestimating the complexity of the project. This is not just a labeling issue; it involves multiple departments and functions, including suppliers and distributors. It requires time, money and resources.”
[more]Maetrics’ European Managing Director Outlines The Demands And Costs Of Implementation, At Med-Tech Innovation Expo.
[more](New York, NY) In the last few years, the fastest growing item cited in FDA warning letters to medical device and pharmaceutical companies is the identification of insufficient CAPA (Corrective and Preventive Action) programs as a source of significant quality system weakness. Debara R. Reese, Vice President, Quality and Compliance, at global life sciences compliance consulting firm, Maetrics, will speak on “Effective CAPA Systems” at MD&M East, at Javits Center in New York on June 10 at 1:20 p.m., one of the largest medical device conferences in the U.S.
[more](San Diego, California USA) During the last few years, there has been growing attention given by the Food and Drug Administration (FDA) to the implementation of corrective and preventive actions (CAPA) at medical device and pharmaceutical companies. Inspections and actions by the FDA are as concerned about the process for identifying and correcting an issue and making sure it doesn’t happen again, as it is about the issue itself.
[more]Indianapolis – (March 10, 2015) – Maetrics, the global leader in life sciences consulting, today announced that Steve Cottrell, previously vice president of sales, will assume the role of company president.
Cottrell has demonstrated commendable success since joining Maetrics in 2013. Prior to that, Cottrell served in executive positions at DOCS, a division of the global clinical research organization ICON plc; i3 Research, a division of United Health; as well as inVentiv Health and AAI Pharma.
[more]Zurich – May 28, 2015 – Maetrics, an international leader in life sciences consulting, successfully hosted its first event in Zurich, Switzerland today. The conference, “The Cost of Non-Compliance – How New Regulation is Re-shaping the Medical Technology Industry,” was made available to an exclusive audience of industry executives.
[more]Indianapolis, Ind. – June 13, 2015 – Maetrics, an international leader in life sciences consulting, recently partnered with Outreach Inc. to provide laptops for a class of 23 high school graduates. Outreach Inc. is a faith-based nonprofit organization that helps homeless teens find stability and transform their lives. The graduates will go on to pursue their studies, work full-time or learn a trade. Read more about the graduates and their post-graduation plans in the Indianapolis Star.
[more]Chicago, Illinois – September 21st & 22nd, 2015. The American Medical Device Summit sets the standard on how the industry should connect and exchange ideas. This year, Norm Rabin spoke on Global Quality Workflow, outlining a 5-step transition from manual to automated compliance processes. Norm’s full presentation can be found here: SlideShare – Global Quality Workflow – Manual to Automated Compliance Process
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