Featured Articles
-
Selecting A Strategic Partner For Your Combination Product
It is imperative to choose an experienced partner that can ensure the highest quality products, minimize supply chain disruptions, and efficiently bring safe, effective drug products to patients.
-
Evaluate CCI Of Vial And Syringe Systems Over Time And Temperature
Combining techniques, such as Residual Seal Force, tracer gas analysis, and headspace analysis, enables a more complete and quantified measure of CCI for vial and syringe combinations.
-
Trends In Combination Products
As demand grows for more patient-centric drug delivery via self-administration, combination products are on the rise. Explore three major regulatory themes to consider when producing drug/device combination products.
-
Parenteral Packaging And Delivery Systems: Container Closure Integrity
Review the chapter, USP <1207> Package Integrity Evaluation – Sterile Products, which covers CCI and different methods of selection and validation.
-
Guidelines For Selecting A Medical Device Contract Manufacturer
Consider these guidelines when evaluating potential device contract manufacturers to choose one that will be the best fit for your company.
-
Maximize Global Regulatory Collaboration
When marketing a combination product globally, pharmaceutical manufacturers and drug delivery technology providers must have a collaborative infrastructure based on strategic alignment, proactive regulatory awareness, lifecycle support, and continuous improvement globally.
-
The Role Of The Contract Manufacturer In Medical Device Development
With a trusted contract manufacturing partner, pharma companies can ensure that their innovative therapies come to market efficiently without compromising the quality of the drug and its delivery system.