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As a drug developer, you’re under pressure to accelerate timelines while remaining conscious of development costs, quality, and regulatory requirements.
Therapies are increasingly complex, and patient and payor expectations are growing, which drives demand for more intricate drug delivery systems and results in new regulations.
Both drug and product development are challenging in their own right. Add the complexity of developing a combination product and constant changes to regulations, it is no wonder drug developers often make errors in their development path. Do you have the expertise to interpret the regulations and avoid compliance challenges?
Developing a combination product requires industry know how from concept through commercialization. To fill in the gaps, you may rely on multiple suppliers, but managing this complex supply chain requires substantial resources and exposes you to risk.
As therapies become more complex and shift towards self-administration, you're pressed to bring more intricate devices to market that are also easy to use. Evolving regulations require you to prove your drug, containment and delivery system are reliable and safe.
As technology evolves to meet the needs of patients, device options are expanded to cover multiple delivery profiles and drug types.
Assisting customers in designing studies while navigating the challenging and evolving regulatory landscape for combinations products.
Supporting customers with solutions to mitigate risk, improve operational efficiencies, reduce operating costs and delivery value to our medtech and pharma partners.
For customers seeking value-added assembly, from multi-component, complex assemblies that are manually assembled to high-speed assembly systems.
In many instances, injectable pharmaceuticals need to be administered by patients or their caregivers rather than by healthcare professionals. The process can be greatly simplified with the use of auto-injectors.
Today’s fill/finish equipment technologies present various options to meet today’s manufacturing requirements including the flexibility to launch with multiple delivery presentations from vials, Pre-filled syringes to combination devices.