Take Complexity and Risk Out of Regulatory Compliance

Novo Nordisk Pharmatech’s high-purity, nontherapeutic insulin is sourced directly from the Novo Nordisk parent company, the world’s largest insulin producer. The product consists of insulin human crystals that are biosynthetically produced by recombinant microbial expression in yeast.

Insulin human AF stimulates the proliferation of cells and enhances the yield, and it is a key component in serum-free growth media for mammalian cells. Insulin human AF is used for manufacturing monoclonal antibodies, virus vaccines, gene therapies, and other biological drug products approved by regulatory agencies worldwide, including FDA and EMA.

Safeguarding Your Regulatory Compliance
If you manufacture products for a market outside of your own, ensuring regulatory compliance can be particularly difficult. You must stay up to date with changes, navigate language barriers, and meet requirements above the official guidelines. Our one-stop regulatory support provides you with everything you need quickly and conveniently. Whether your needs are more straightforward or you require dedicated support, our expert team is here to take the complexity and risk out of regulatory compliance for your whole product life cycle.

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