Tag Archives: pharmaceutical consulting firm

  • Issues for Device Combination Products

    The development of medical device combination products convenience packages continues to present interesting technical and regulatory issues. Inclusion of pre-sterilized syringes and applicators as part of these products poses problems for manufacturers and distributors due to the opportunity for post sterilization residual contamination and/or plastic leachables/extractables. Most device convenience kits are ETO sterilized and this can leave ETO residuals on applicators and syringes if …

  • BARDA and their Countermeasures Initiative

    Last month was the PHEMCE conference in Washington DC which translated the governments approach to countermeasures production for the next decade or so. From the discussions it appears that BARDA will be placing a greater focus on CBRN (Chemical, Biological, Radiological & Nuclear) countermeasures issues in the future than it has in the preceding 5 years when there’s been a heavy emphasis on flu related countermeasures, H1N1, for example. In addressing these issues there would appear to …

  • 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 and PAT – The Next Level For Pharma

    In 2003 the FDA announced the Process Analytical Technology (PAT) initiative to “encourage the voluntary development and implementation of innovative pharmaceutical manufacturing and quality assurance.” This initiative was designed to improve process efficiency of both manufacturing and regulatory phases, and is comprised of four components: data analysis, process analytical tools, process monitoring, and continuous feedback. The quality-by-design aspect of PAT will reduce cycle time thus …

  • 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

    Over the next five years, pharmaceutical consulting could be positioned to play an increasingly critical role, according to the latest estimates from the Business Monitor International’s Pharmaceuticals & Healthcare Business Environment Ratings. Although the US pharmaceuticals market is currently ranked first both regionally and internationally, projections for the fourth quarter of 2010 and beyond indicate that industry growth is likely to be meager at best. Indeed, the compound …

  • Lean Manufacturing for the Competitive Edge

    Factors within the pharmaceutical industry have combined with economy-related issues to force pharmaceutical companies to seek new ways of maintaining or regaining their competitive edge.  Increasing globalization, scarcity of new blockbuster drugs, growing regulatory burdens, the failing we-are-different attitude, and a longstanding emphasis on R&D at the expense of production are all making it necessary for pharmaceutical manufacturers to strive for lower costs, increased efficiency and …

  • Pharmaceutical Consultants Broaden the Scope

    It is a widely accepted fact that consultants assist companies by analyzing and assessing each individual situation and set of circumstances. Consultants then work with that company to design and implement appropriate programs, policies, and procedures based on those results. The final step is to advise, guide, and provide training in order to take the company from where they are now to where they need, and want to be. What’s far less well understood, however, is the value that …

  • The Right Sequence for Lean Manufacturing Implementation

    For a pharmaceutical manufacturer, implementing lean manufacturing can be a fairly seamless and efficient process.  It can also be fraught with resistance, incorrect perceptions and end up only a partial implementation.  The negative perceptions and attitudes that impede a successful, effective implementation of lean manufacturing solutions generally start at the top, and is where lean manufacturing consultants can provide the most effective assistance and guidance. The manufacturing arena is …

  • Hiring a Pharmaceutical Consultant: 7 Steps to Success

    … microbial/fermentation technology, as well as biochemical engineering, and Denise with training and experience in the legal arena. 3. Flexibility (Vision/Perspective) One of the worst things that can happen when you engage the services of a pharmaceutical consulting firm is that the consultants come in with a preconceived and mostly solidified idea of what needs to be done. This outlook and attitude leads to proposed solutions that probably are not going to be optimum for your specific …

  • The Continuing Journey of Lean Manufacturing in the Pharmaceutical Industry

    There is no doubt that lean manufacturing solutions do work, however, implementation is not a one shot deal – rather it is an ongoing process of continually striving for improvement. While there obviously has to be an emphasis placed on quality, once it is attained the focus must shift to sustaining quality through fostering a culture of continuous improvement. Toyota recently learned this lesson the hard way. The Toyota production system has been the touchstone for almost every lean …

  • Making Relationships Count With Life Sciences Consulting

      A relatively new development in the life sciences industry is the growing use of contract manufacturing organizations or CMO’s. In response to decreasing profit margins, continuing patent expirations, and the concomitant diminishing product pipelines, companies are turning to CMOs as a way to reduce costs and still invest in R&D. This new development also opens the door much wider for life sciences consulting. In the 2009 Annual Outsourcing Survey conducted by Contract Pharma, 29% …