Tag Archives: pharmaceutical company

  • The Smart Road to Pharmaceutical Consulting

    Expenses surrounding R&D, production, regulatory compliance, marketing, and product distribution continue to increase. The cost of medication and various kinds of specialized health services continue to rise. In addition, the number of blockbuster drugs is dwindling, safety concerns are growing, and greater government intervention looms. All of this means that the value of and the return on investment for pharmaceutical consulting services are also increasing. Staying competitive and …

  • Behind The Increasing Need for Pharmaceutical Consultants

    … may be a viable solution, it carries with it potential dangers that could be very costly. According to Nigel Smart of the Smart Consulting Group The company is still responsible for meeting drug-manufacturing regulations, as well as other government requirements. Ultimately, the holder of the license—the pharmaceutical company or biotech—is the one who will have to answer to the government, or deal with lawsuits. Smart offers this warning: “As one goes farther afield from one’s home …

  • FDA Inspection Wizard: What’s Scary Can Turn Out to Be a Piece of Cake

    … you will take to solve the situation. Get the help of your sponsor, because the pharmaceutical company has lots to lose too, and contact your pharmaceutical consultant for guidance and support. If you do not respond correctly, you may be banned from performing other studies; your study data, or even the whole marketing application, can be rejected; and you may even face criminal charges. The EIR is available, upon request, to the site, sponsor, and general public, after 4 to 6 months through the …

  • How to Perform a Mock Audit

    … may upset people, make them feel they were treated unfairly or criticized, or that the issues uncovered could be held against them. Managers and executives who participated must make sure everyone understands that the results will not affect anyone’s job; otherwise, future mock audits will lose effectiveness due to employee fear. Mock audits must be a regular practice of any pharmaceutical company’s training program; thus, it requires full management support and staff participation. …

  • 5 Important Factors to Measure in Your Lean Process Strategy

    … processes in your company.  After that you will need to train your employees accordingly. Many companies have tried to find success by copying Lean strategies from other successful companies with little or no success.  This is because every company is different, with different needs and different procedures.  If you’re looking to improve your Lean strategies at your pharmaceutical company, be sure to contact a local pharmaceutical consultancy firm for more information. If you liked this …

  • How to Do a SWOT Analysis as Part of a Business Plan or Business Process Strategy

    There are many types of analyses that help to illuminate potential issues as well as areas of opportunity for a new business – one is known as a SWOT or Strengths – Weaknesses – Opportunities and Threats analysis.   This type of analysis forces the executive team of any pharmaceutical company to brainstorm these critical items before launching a new company, new division or new product – which may help decide whether or not to venture into this new direction. Strengths are attributes …

  • The Lean Laboratory of the 21st Century

    … These fears stem from a concern that a Lean manufacturing approach will cut down on the quality control of a product, resulting in lower quality products, which may result in lawsuits or non FDA approval.  But as more companies in the pharmaceutical industry begin to use Lean strategy with great success, many in the field are optimistic of its effectiveness in the future. If your pharmaceutical company is looking to apply Lean strategies to your business, then contact a pharmaceutical …

  • REMS Risk Management Strategies

    … any potential side effects.  New safety information may be defined as any information that might be derived from a clinical trial, adverse event reports, post approval studies, or any other scientific information that may have emerged. If your pharmaceutical company is expecting a REMS review, the most important thing you can do is to develop a strong REMS strategy to counter your upcoming inspection.  The best way to do this is to contact a pharmaceutical consultancy firm that specializes in …

  • Building an Optimal Quality System

    … not only meet the goals and standards of the pharmaceutical company, but also be aligned with the company’s system management approach as well as other departments in the company. If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source). …

  • Important Information about Lab Ergonomics

    … these tips: –    Store heavy objects on lower shelves. –    Use a stable stool or ladder to reach overhead shelves. –    Do not twist while you lift. –    Use rotating carrousels to store materials close to the worker. The well being of personnel is vital for the good functioning of any laboratory.  Any pharmaceutical consultant will agree that people are a pharmaceutical company’s strongest asset; by caring for their health you are taking your company far …

  • Building Value in a Biotech Company Through Partnerships

    … fast way to build value, they very often fail to deliver. The most reliable   way for a biotech company to become successful is to develop a product that meets a specific need and thus, is bought by many customers. However, getting there is not easy. Biotech companies normally strive to partner with a pharmaceutical company as a way to validate their technology and ensure financing.  These partnerships possess many benefits, but also pose challenges and disadvantages, namely: an increasing …