Aptar Pharma
Services
Aptar Pharma Services provides customers with the integrated services and support they need to advance their drug device combination products from discovery to launch, and everywhere in between. We combine decades of world class scientific and regulatory expertise, with an unrivalled knowledge of specialized drug delivery systems, to create complete pharmaceutical development and support services that customers need.
Aptar has designed their Pharma Services offering to accelerate and derisk the development and manufacturing processes, inspiring confidence in customers. Aptar Pharma Services is a simple unified solution to bring new drug delivery products to market faster.
A Holistic Approach to Pharmaceutical Services
Aptar Pharma Services team offer expert advice for the entire drug product development process to efficiently advance and derisk projects for our customers. From nasal, respiratory, pulmonary, injectables, dermal, to eye care, Aptar Pharma Services can support your unique development needs starting with the development of delivery systems for devices and formulation development, through clinical trials and regulatory filings, all the way to market launch and post-launch activities. We take a holistic approach that brings together the experts in each specialty area ensuring that we fully optimize drug product and delivery device performance.
Inhalation Services – Nanopharm
Nanopharm specializes in offering Contract Research organization (CRO) services for intranasal and inhaled drug products. From R&D to cGMP, our product development and analytical testing services can advance OINDPs to market using our proprietary in vitro in silico models and computational pharmacokinetics (PBPK).
Injectable Services – Gateway Analytical
Gateway Analytical is focused on cGMP analytical services that support injectable (parenteral) products with specialized foreign particulate matter (FPM) analysis, container closure integrity testing (CCIT), sub-visible particulate release testing and extractable and leachable analysis.
Patient Services – Noble / Metaphase
Leaders in medical device training solutions, adherence programs, patient onboarding strategies, human use studies and creating multisensory products that successfully bring new products to patients and Health Care Professionals (HCPs).
Combination Product & Device Services
We’ve applied decades of delivery systems for devices with cutting edge regulatory, development and scientific expertise to provide our customers with complete services that integrate our drug delivery systems.
Inhalation Services – Nanopharm
Nanopharm’s specialized CRO services are dedicated to advancing the development of intranasal and inhaled drug products. As OINDP products are very complex to develop, specialized tools and knowledge are required to efficiently advance new products, while minimizing risks for their development. Nanopharm achieves this with experienced OINDP scientists, modern facilities, leading-edge technologies and scientific approaches you won’t find elsewhere. Our development services support a wide range of devices including dry powder inhalers (DPIs), pressurized metered dose inhalers (pMDIs), as well as liquid and powder nasal spray devices.
Our proprietary SmartTrack™ platform uses a range of in vitro in silico models and physiologically based pharmacokinetic (PBPK) computational simulations to demonstrate bioequivalence of inhaled generic products with their reference products. And all without the need for costly or time consuming comparative clinical endpoint (CCEP) studies.
Nanopharm’s labs provide cGMP services to support IVBE and CMC requirements as well as product release for reliable and compliant testing and validation. We offer the specialized capability to characterize nasal suspension generic drug products using Nanopharm’s Morphologically-Directed Raman Spectroscopy (MDRS) system for simultaneous morphology imaging comparisons and chemical analysis of complex multi-component formulations.
Nanopharm also provides its spray drying and particle engineering expertise to optimize powders for intranasal and respiratory Dry Powder Inhaler (DPI) products. As OINDP development specialists we offer our extensive regulatory experience to customers through world-class consultancy services, ensuring product development is derisked and accelerated to get your product to market.
Injectable Services – Gateway Analytical
Gateway Analytical offers highly specialized cGMP laboratory services supporting the needs of injectable (parenteral) products. Our laboratory services include industry-leading foreign particulate matter (FPM) analysis, container closure integrity testing (CCIT), sub-visible particulate release testing as well as predictive analytical services. Gateway Analytical’s scientists take a forensic problem-solving approach coupled with state-of-the-art analyses to solve particulate matter investigations. Gateway Analytical has also developed a particulate identification database that helps quickly and reliably identify the particulate matter so that root cause analysis can be performed with ease.
Gateway Analytical also conducts extractable and leachable analysis that provides a greater understanding of potential product-packaging interactions that may impact product stability and safety. All of these specialized services are available in our fully certified cGMP compliant laboratory, holding ISO 9001 and 17025 accreditations, and have been successfully inspected by the U.S. FDA.
Gateway Analytical is dedicated to demonstrating our commitment to providing only the highest quality laboratory services supporting parenteral product requirements.
Patient Services – Noble / Metaphase
Noble is an established leader in medical device training solutions, adherence programs, patient onboarding strategies, human use studies and creating multisensory products that successfully bring new products to patients. We apply research-driven insights, innovative technologies, and patient-focused solutions to improve patient outcomes when administering combination products. Noble delivers Health Care Professional (HCP) training and support that enables efficient onboarding and patient adherence with new products which ultimately contributes to improved patient outcomes.
Noble works closely with Metaphase, our industry leading design, ergonomics, and handheld product research group. Together, as part of Aptar Pharma Services, Noble provides complete onboarding, adherence, and human factor services to drug product developers around the world.
Combination Product & Device Services
Combination products are complex. Their development must consider the device, formulation, and the patient all under today’s strict drug development regulations. Aptar Pharma applies decades of industry leading device knowledge and cutting-edge development science to provide customers with comprehensive support services that bring combination products to market. U.S. FDA Combination Product and EU Medical Device Regulations (MDR regulations) require a host of specialized testing, support, and validation in order to successfully navigate the complex regulatory filing processes. And that doesn’t consider the additional services needed to scale-up, manufacture, and release combination products or fulfill the unique requirements of emergency use products utilizing a device.
Aptar Pharma can offer complete support services to emerging start-ups that need the most data, experience, and technical capabilities, to achieve their goals faster. Global Pharmaceutical customers with sophisticated in-house device development teams can utilize only the specialized combination product services that they need. Either way, Aptar Pharma Services’ flexible Combination Product & Device Services provide customers with the confidence that only years of dedication to specialized drug delivery device development can offer.
In today’s complex world, it’s not enough to just prove a drug product is safe and effective, but one must prove that the entire drug delivery system, including the device, formulation and human use factors are safe for the patient. Access to Aptar Pharma’s Combination Product & Device Services can include virtually everything you need, including the data, know-how, testing, documentation and support to streamline and derisk your new combination product or medical device.
Aptar Pharma Services – Integrated Services for Every Step of
the Drug Development Process
With a full range of highly specialized services covering everything you need including product development, device, drug delivery, manufacturing and regulatory support, Aptar Pharma Services was built to accelerate and derisk even the most complex drug development program.
Contact us today to learn more about how Aptar Pharma Services can provide complete pharmaceutical solutions that accelerate and derisk your drug delivery project.
