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.