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.
Multiple Ways to Partner with our Regulatory Support Services Team
We offer expertise to support you through successful development and submission of your new product, and during your product’s lifecycle management.
Regulatory Document Support
We can create and provide a range of documents, study reports and other services to support both your new regulatory submissions and the lifecycle management of your product’s submissions.
Regulatory Dossier Authoring
We can create and update regulatory dossiers to support both your new regulatory submissions and the lifecycle management of your product’s submissions.
Regulatory Dossier Submissions
Our global regulatory support can also include the submission of regulatory dossiers, according to the countries targeted for your product (e.g. DMFs for your submission in the US, in Canada or in China).
Combination Product Guidance
As experts in combination product regulations, we can offer strategic and operational support to get your product to market.
In-vitro Bioequivalence Reports
Our scientists can help screen your products and develop bioequivalence evaluations and reports, to help your new product development.
FDA/PAI Audit Support
Pre-approval audit support helps assure the FDA that our production sites can manufacture the solutions and that the data submitted is accurate and complete.
We support all modifications to product, process and organization, from initiation of the request to the implementation, via a global and systematic digitalized system
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