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  • Navigating the Complexities of Combination Product Regulations and Patents

    Navigating Regulatory and Patent Challenges in the Combination Products Space The combination products sector is an exciting intersection of drugs, devices, and biologics, offering immense potential to revolutionize healthcare. However, with this potential comes a [...]

  • Off-label uses… the Windex of the medical field?

    You’ve heard the term, “cure-all”, I’m sure, but as we all know, there is no real “cure-all” in life. If you ever watched the movie, “My Big Fat Greek Wedding”, then you are all too familiar [...]

  • Establishing Control Over the Quality of Your Biologic

    When it comes to creating any form of medication, reputation is everything. Customers expect their medicine to have the correct ingredients, to be safe, and to work as described, with limited side effects. Should a [...]

  • Delays in Biomanufacturing: What’s at the root of the problem?

    Biomanufacturing is a difficult process, as anyone who works in the field understands, and there continues to be a great need for the work of biomanufacturing to become less expensive, more streamlined, and all around [...]

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