Regulatory Support

For more than 25 years, Aptar Pharma’s expert regulatory teams have successfully supported our customers’ regulatory submissions around the world.

Unparalleled Expertise in Supporting Regulatory Submissions Worldwide

Proven track record

In the past five years alone, we have successfully achieved more than 100 approved NDAs and ANDAs, 30 DMFs and 40 INDs with the U.S. Food and Drug Administration (FDA).

 

Wide-ranging experience in many therapeutic areas

Our experience includes asthma, COPD, dermal, eye care, pain management and CNS treatments, both small and large molecule, sterile to non-sterile, and NCEs to established-dosage forms.

 

Specific expertise in combination products

We offer both experience and expertise in combination products for ophthalmic dispensers, pMDIs, DPIs and nasal sprays.

Global network with local care

Our regulatory affairs experts are assigned to specific projects, and are always on hand to help guide you through the increasingly complex and constantly changing regulatory landscape.

 

Support at every stage of your project development

We offer robust, expert guidance at all levels, including customer support packages and submissions reviews.

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