Tag Archives: drug

  • WHO Ebola Vaccine Meeting

    … partners moving in tandem and at the same accelerated pace. More than 90 participants, including some of the world’s leading scientists, came, on short notice, from national and university research institutions, also in Africa, government health agencies, ministries of health and foreign affairs, national security councils, and several offices of Prime Ministers and Presidents. Also represented were national and regional drug regulatory authorities, the MSF (Doctors Without Borders) medical …

  • Venturing into the Bold World of Combination Products

    – By Michael Hemenway For a traditional medical device company contemplating a decision to develop a combination drug-device product, the question of whether or not to pursue this type of product should be weighed carefully.  While there might be a benefit to the patient from such a product, the benefit should be compelling and perhaps more importantly from a business perspective, the profit uplift from having a drug associated with the product should be large enough to more than offset …

  • NDC codes: National Drug Codes and How They are Assigned

    The NDC code is a 10 digit code that is applied to uniquely identify products having a drug registry component. The number is a 3 segment number in terms of its construction and the various components correspond to sections responsible for the label, the product and the packaging. The first section identifies the labeler code, is assigned by the FDA and it identifies any manufacturer (including re-packagers or re-labelers) or distributer (under their own name) of the drug or drug containing …

  • Risk Management as part of your Lean Compliance Strategy to enable you to meet your Compliance Obligations.

    In a regulated industry like the Life Sciences Industry which covers Pharmaceutical, Biologics, Biotechnology drugs, Medical Devices, Medical Device/drug Combination Products, Diagnostics and Tissue Therapies, adherence to strict regulatory& quality compliance  principles is a given. However, over killing what you are doing can be very costly and may be forcing cuts in other vital areas of the commercial operation. That’s why using Risk Assessment Techniques to develop a Lean Compliance …

  • Pharmaceutical Consultants-The Key to a Rapidly Changing Industry

    … organizations are arranging themselves into industry-specialized groups.” This means that when a drug company turns to a pharmaceutical consulting firm to bolster profitability and hone its competitive edge, the consultants need to have a broad, deep base of knowledge and expertise. Perhaps even more important, good consultants also serve in a sort of “prophetic” capacity of identifying and keeping abreast of developing trends in a rapidly changing industry, preparing companies …

  • Lean Manufacturing Solves Drug Recalls and Bad Press

    In 2009, drug recalls reached an unprecedented high of 1,748. These recalls are attributable, in large part, to outsourcing and indiscriminate cost cutting. Today, more recent drug recalls and the resulting bad press are forcing the pharmaceutical industry to shift their focus to the manufacturing aspect of the drug production process. This latest rash of drug recalls has also intensified both consumer and media backlash against the pharmaceutical industry. A few examples of the most recent …

  • Pharmaceutical Consulting and BMI’s 4th Quarter Update

    … annual growth rate (CAGR) is projected to be only 1.76% over the next five years. This slowdown is the result of several factors, including patent expirations, increasing FDA scrutiny, pending healthcare reform, the overall economic climate, and decreased demand for medications and medical services. In this difficult environment, pharmaceutical consultants could prove to be the key factor that enables many drug manufacturers to maintain a competitive edge. Intimately bound together, the …

  • Lean Manufacturing for the Competitive Edge

    … factory management, inventory handling, time management, and all non-value-added activities.  One of the major drivers behind pharmaceutical’s adoption of lean manufacturing techniques as a means to eliminate waste is globalization.  With the buffer provided by blockbuster drugs eliminated, increasing global competition together with the consequent shorter periods of drug exclusivity has resulted in the need for everything to happen faster. Still, quality remains paramount, and therein …

  • Microbiology: Transcending Waste With Lean Manufacturing

      Today’s pharmaceutical industry is beginning to embrace the lean manufacturing process a little more enthusiastically than in previous years. Companies need, and want, to ensure operational excellence, improve quality, eliminate waste and non-value-added activities, become more responsive to customer demand, and improve efficiency—all of which lean manufacturing techniques can deliver. With the record 1,742 drug recalls in 2009, a much higher emphasis is being placed on quality …

  • The Smart Road to Pharmaceutical Consulting

    … industry experience. Smart Consulting offers a broad range of services in several areas—vaccines, lean manufacturing, quality and compliance, drug/device combination products, FDA regulations, and FTC concerns—with special expertise and interest in quality compliance, quality audits, laboratory strategies, and manufacturing solutions. While many of these same consulting services can be found in many other consulting firms, two things set Smart Consulting apart from the others: 1) their …

  • Counteracting Expanding FDA Reporting Requirements Through Lean Manufacturing

    The pharmaceutical industry faces ever higher hurdles in the 21st century. With the recent rash of drug recalls – 2009 is the record year so far – one hurdle that is wreaking havoc with previous profit margins and just keeps growing is that of expanding regulatory compliance burdens and reporting requirements. And now the FDA appears to be raising the bar even higher with its proposed amendments to the Investigational New drug Safety Reporting Requirements, which take effect 28 March …