Accelerated development with a trusted partnerfrom R&D to market and beyond

Aptar Pharma Services

Delivering solutions, shaping the future.Delivering solutions, shaping the future.

Key reasons to partner

with us

Leading provider of

drug delivery systems and

services

70+ years’

experience in device

development

170+ marketed

prescription drugs worldwide use

our devices

25+ years of global

experience supporting regulatory

submissions

600+ patents offering

additional IP protection

100+ approved

NDAs/ANDAs and 40 INDs with U.S. FDA

in past 5 years

Accelerated development with a trusted partnerfrom R&D to market and beyond

Aptar Pharma Services

Let us put our expertise to work for you. Partner with Aptar Pharma on your next development journey, and let us help you succeed…faster! To find out more about how Aptar Pharma can accelerate your development journey, contact your Aptar Pharma Sales Representative in your region or visit pharma.aptar.com

Delivering solutions, shaping the future.

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Aptar Pharma is a leading global provider of drug delivery systems and services, enabling safe, convenient and compliant medicine delivery.

We have decades of experience across pulmonary, nasal, dermal, eye care and injectable delivery routes. We partner with customers to provide complete and proven solutions to their drug delivery challenges.

Our start-to-finish solution services are built around our extensive range of trusted analytical, laboratory and regulatory support, designed to accompany you from R&D to market launch and beyond.

This comprehensive portfolio of stage-specific service packages proactively addresses regulatory needs, including Combination Product requirements, to help accelerate approval. We have a successful track record with the U.S. FDA, with more than 100 approved NDAs and ANDAs, and 40 INDs in the past 5 years.

• Test methods to support batch release

• ICH Stability Program

• Impurities and degradation control

• Spray characterization

• Structural equivalence (Gel structure, deposition, spreading, dissolution, and absorption)

• Chemical Specific Particle Sizing

• Finished product specification

• Temperature cycling and Aging studies

• Established Extractables and related DMF file

• Ready-to-submit Extractables report

• Routine testing and C of A

• Validation of Extractable methods

• Extractable and Leachable reports

• Leachable studies performed on stability

• Fully integrated design house with rapid prototyping

• Quality by Design customization with complete Design History File

• Customization of branding and aesthetics

• Human Factor driven customizations

• Formulation, indication and patient specific device optimization

For this phase of development, Aptar’s support begins with device selection and continues up to the submission of the Investigational New Drug application.

• Aptar Pharma QuickStartTM kits

• Device design and rapid prototyping

• Filling and assembly support (animal adapters and filling kit)

• In vitro feasibility assessments and comparability

• Actuation System Actuation Profile

• Container Closure Integrity

• Nasal cast deposition evaluation

• Biocompatibility testing

• Ready-to-submit IND package

• Method development and validation (Test and Reference Listed Drug – RLD)

• Feasibility assessment and comparability evaluation

• Dose performance testing

• Filling and assembly support

• Drug product and spray characterization

• Priming and Repriming

• Labeling, randomization and blinding for IVBE

• Statistical analysis (population bioequivalence)

• Ready to submit IVBE report

• Establishment of CMC acceptance criteria

• Drug product clinical release

• Device trainers for patient onboarding

• Formative Human Factor Studies

• Ready to submit HFS strategy

• Threshold comparative analysis report

Connected devices can provide improved health outcomes through patient education and dose adherence. We offer Connected Device platforms across Aptar Pharma’s drug delivery systems to deliver fully integrated connected delivery systems into patients’ hands.

• Clinical trial optimization

• Patient onboarding

• Fully integrated connected platform delivery systems in nasal, respiratory, ophthalmic, dermal and injectables, amongst others

This service is specifically designed to close the gap between the device component and the finished product by proactively addressing common deficiencies and ensuring regulatory guidelines are met.

• Design History File

• Risk evaluation and mitigation strategy

• Release specs for individual device constituent parts

• Reliability

• FDA/PAI audit support

• Investigation management

• Change control management

• Data trending for Critical Quality Attributes

• Device trainer kits for commercial sales support

• Annual Product Review

Quality

Approved

R&D to Phase 1

Chemistry Manufacturing and Controls

Extractables and

Leachables

In VitroBioequivalence

Clinical Studies Support

Digital Health

Regulatory Submission

Support

Customizations

Post-Launch

Let us put our expertise to work for you. Partner with Aptar Pharma on your next development journey, and let us help you succeed…faster!

100+ NDAs/ANDAs40+ INDs with U.S. FDA in the past 5 yearsRegulatory

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