Tag Archives: company

  • Best Practices of Smart Consultants

    … consulting company, we encounter a vast array of personalities within our client/business relations. From there we began to ponder: What kind of consultants do we consider near and dear to our heart? Is it the cruise ship director? The person who is likely to sit back and watch their team assign roles and work for each other while they help to boost the overall team’s morale? Although keeping it positive is an amazing and sometimes hard to find trait among people in this industry, there is …

  • Consolidation Activity in the Generic Sector

    … developed to assume that products will remain available to consumers at the right price. As producers drop out, monopolies are developed and the Federal Trade Commission is obliged to step in to protect competition and consumer choice.  This involves its own level of management which can also put stress on the company to deliver products to the consumer. So beneath the economic/business surface news of an acquisition/there’s the underlying practical considerations which may be overlooked …

  • 483 Audit Forms

    So what’s with this 483 audit form and where do I go from here? Faced with a 483 audit form? If this is the first time your company has received a document of this nature your initial thoughts may be… now what? In order to understand the true implications of a 483 citation, it may help to think of it in terms of a speeding ticket. It’s a road block or a cause for reevaluation of your current state. Although not necessarily a serious offense, it’s an important warning to your company that …

  • Value Stream Mapping

    Value Stream Mapping Lean Biomanufacturing, by Dr. Nigel J. Smart No one company can do it all. It’s nearly impossible to implement every fresh, new research method that enters the market into your company’s regimen. To put it simply, not every method may best fit your company’s overall goals. Understanding this key concept will be invaluable to your research team’s overall operations. Science is ever-changing and although the industry is bursting with excitement, one can get a bit in …

  • Lean Biomanufacturing: Keeping Your Eye on the Quality Goal

    … damage of patient’s lives. From experience we know that these situations kill the product commercially and ultimately harm the brand of the company for future pipeline products. So the case for building and maintaining elements necessary to assure appropriate quality standards in a medical products manufacturing process are integral in the overall strategy for production and sale of the product. In more recent times Toyota’s Lean approach to manufacturing has been blamed for the fall in …

  • The Pharmaceutical Consultants Role in Lean Manufacturing/Biomanufacturing Processes

    … company and the workforce equally. This communication role will be vital if the grassroots is to be activated and ideas and practices are to go viral in terms of their acceptance. Through a structured training program the consultant can educate the senior management, core team and workforce in the philosophy and importance of the key steps that will need to be embraced and lay the necessary groundwork to ensure that the initiative gathers continuous momentum. When the going gets tough the …

  • 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

    … material. The second section identifies the product code which includes the specific strength, dosage form and formulation for the company. The third section identifies the packaging code and this corresponds to the package size and type. This part together with the product code is provided by the company filing the NDC application. In practice NDC codes follow the following convention: 4-4-2, 5-3-2 or 5-4-1, where the second and third parts are determined by the operating convention within each …

  • Do Start up Life Science Companies need Quality Management Systems?

    So you may be a start-up or virtual life sciences company, but you still have a requirement to have a Quality System to develop your pharmaceutical/life sciences products. That’s true if you are a company that is regulated by the FDA and major international regulatory agencies that conform to ICH guidelines. Although you’re not likely to be inspected as an early stage company, regulators still expect that developers of human products must be stage appropriate managed in terms of compliance …

  • Change Management; A Vital Part of the Lean Mechanism within the Life Sciences Industry.

    … and before any deployment plans are finalized. Often this is best performed by an outside group such as a pharmaceutical consulting company, because this allows for a more objective assessment to be developed. One key point to address is to define for the workforce what the new “Desired State” for the company looks like. It’s very important that the management and workforce clearly understands what they are working towards and how they know when they have arrived at that point. Goals and …

  • The Use of Process Mapping, Value Stream Mapping and Score Cards in developing a Lean Culture in Life Sciences Companies.

    … (in the EU). This plays a significant role in changing how certain elements are used and makes the opportunity for successful implementation more of a challenge. That said simple techniques such as Process Mapping, Value Stream Mapping & the use of Score Cards are often employed sparingly to the detriment of the operating company. In our experience, simply by initiating the use of these tools and techniques, massive gains can be made in the streamlining of processes which result in huge …