Aspen API. Our regulatory support team
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 across the world. We know, are involved with, and act proactively on changes in monographs and on governmental regulations and expectations.
Aspen API is an active and valued member of APIC and as such directly involved in discussions within EMA, FDA, EDQM and ICH. We play a key role on several expert panels and also participate in both USP and EP expert groups.
In our knowledge base you can find information such as typical CoA’s, solvent statements, origin statements and safety data sheets. Do you want to have a account, just contact us.