Tag Archives: contact

  • Leachables and Extractables in Biopharmaceutical Processing

    … With all this activity going on its often helpful to solicit the help of a consultant that is aware of the issue s to help guide a path forward. In developing protein therapeutics that may be sensitive to contact with rubber and plastic components, the potential effect of Leachables over time can become a critical processing consideration. To help to address this issue, part of the modern approach is to use Risk Assessment and Risk Mitigation strategies to first quantify the extent of the …

  • Critical factors in Filing NDC numbers with the FDA

    … different formulations are put into the same size packaging it will require a new NDC number AND if different formulations are used in the same size packaging this will require a new NDC number. Clearly if a formulation changes, this will also trigger a new label too, but the point here is to recognize that these individual categories are individual triggers for new numbers and a regulatory filing. contact us if you need assistance with this process. …

  • Hiring a Pharmaceutical Consultant: 7 Steps to Success

    … built on trust, respect, and mutual benefit and to be available for long-term, ongoing contact. It has been said that good consultants are business therapists whose primary goal is their client’s success. The right pharmaceutical consultant can be an invaluable asset to your organization, someone who can help you maintain, or regain, a competitive edge. But be smart – nobody wants to be stuck in a bad relationship. …

  • The Future of Regenerative Medicine

    … the spinal cord -Going after the goal of regenerating more complex tissues and neo-organs -Tackling big challenges, like the identification of cell sources and clinically relevant cell numbers, the integration of new cells into existing tissue matrices, and the accomplishment of functional properties of tissue equivalents using expanded range of biomaterials contact your life sciences consulting group for more information and guidance on how to make the most of the regenerative medicine market. …

  • The Future of Regenerative Medicine

    … tissues like the spinal cord -Going after the goal of regenerating more complex tissues and neo-organs -Tackling big challenges, like the identification of cell sources and clinically relevant cell numbers, the integration of new cells into existing tissue matrices, and the accomplishment of functional properties of tissue equivalents using expanded range of biomaterials contact your life sciences consulting group for more information and guidance on how to make the most of the regenerative …

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

    … phone call.  The FDA will call to program an inspection at a time that is agreed between both parties and that does not interrupt the site’s activity.  Nevertheless, they will only give you between 5 to 14 days notice, and will spend around 2 to 3 days on site. You are entitled to ask what study they are going to inspect and who should be available during the visit, and contact the study sponsor immediately, because this sponsor can give you good suggestions and they are not directly …

  • The Secret to Tissue Regeneration… In The Body of a Worm?

    … organize themselves to form a normal brain. The team knows that it is crucial to understand the molecular basis for tissue regeneration and remodeling in order to advance in regenerative medicine. The planarians are famous for their incredible regenerative capabilities, and these scientists have been able to characterize the first gene, the Smed-prep, that is necessary for correct anterior fate and patterning during regeneration. contact your pharmaceutical consultant for guidance and more …

  • The Secret to Tissue Regeneration… In The Body of a Worm?

    … cells are unable to organize themselves to form a normal brain. The team knows that it is crucial to understand the molecular basis for tissue regeneration and remodeling in order to advance in regenerative medicine. The planarians are famous for their incredible regenerative capabilities, and these scientists have been able to characterize the first gene, the Smed-prep, that is necessary for correct anterior fate and patterning during regeneration. contact your pharmaceutical consultant for …

  • Advances in Pediatric Personalized Medicine Are Highlighted at Unique International Conference

    … medicine clinic will offer better therapies for children by using various approaches, which include genomic technologies and the cooperation between clinical pharmacologists and pediatric subspecialists. contact your life sciences consulting firm for more information about the future of personalized medicine. …

  • What You Need to Know About Vendor Audits

    … provide a great value to your company and organization, especially, in the system implementation and validation process.  It allows for vendors and buyers to quickly establish relationships that will not only increase product quality, but reduce duplicated testing efforts, and start a new and constructive dialogue between buyer and vendor.  To learn more about how to properly administer vendor audits in your company, contact a leading pharmaceutical consultant in your area. If you liked this …

  • Key Factors in Third Party Testing on Combination Products

    … party testing methods of combination products, then contact your local pharmaceutical consulting firm for more information. 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). …