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Aspen API. Our Regulatory Excellence

At Aspen API we understand your regulatory requirements. Our Customer and Regulatory Support teams are advocates of excellence and are available to you at all stages from development through registration and commercialization. We facilitate your ongoing product support and new product launches worldwide. We are with you every step of your journey.

We have comprehensive regulatory experience in countries all over the world. We know, are involved, and act proactively on changes in monographs and on governmental regulations and expectations. Customers rely on our high quality dossiers and customer oriented support and we provide assurance that their API project is in experienced hands.

Aspen API is an active and valued member of APIC and as such directly involved in discussions within EMA, US FDA, EDQM and ICH. Due to our participation in USP and EP expert groups, we play a key role in several expert panels.

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