Formulation Development – case study

Posted by & filed under Formulation Development.

Issue: Preliminary clinical studies indicated that a combination of a steroidal compound and an enzyme inhibitor were effective in treating an unmet medical need. However, the clinical formulation was not commercially viable and the steroidal component had limited bioavailability and solubility issues. The drug product was not physically stable and the formulation not acceptable for… Read more »

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TECHNOLOGY TRANSFER

Posted by & filed under Industry Trends, Tech Transfer.

Using experience gained managing the global transfer of over 20,000 products, Verta helps clients ensure the successful technology transfer of production to new supply sites globally. We do this by building a fully integrated project plan, which takes you through a proven 10 step process (see diagram below) that identifies the activities and resources required… Read more »

Package and Artwork Design

Posted by & filed under Artwork, Packaging.

Packaging and Artwork Design

Artwork Design Whether launching a new product or enhancing and updating an existing product, we bring over 25+ years of hands-on experience. We specialize in artwork development for small companies who do not have an in-house creative team, meeting both regulatory and commercial requirements. We have worked on over 100 new product launches that included… Read more »

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Data Integrity – Quality and Regulatory Compliance

Posted by & filed under Industry Trends, Quality, Regulatory.

Data Integrity - Ensuring companies maintain Quality and Regulatory Compliance

Data Integrity is not a new issue; indeed, it has been part of WHO, FDA and MHRA guidelines for many years. However, recently, the major regulatory agencies have sought to reinforce the importance of Data Integrity (DI), issuing further guidance and auditing accordingly. It is not just an “India and China” issue where most FDA… Read more »

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