End-to-end Nasal Drug Product Development Support

Effective nasal drug product development demands a fully integrated approach that brings together formulation science, device selection, analytical testing, and GMP-compliant manufacturing of clinical trial materials. The nasal route of administration offers significant therapeutic advantages, including rapid systemic absorption, targeted treatment of nasal conditions, and the potential for nose-to-brain delivery via the olfactory region, providing a path that can bypass the blood–brain barrier. 

Despite these benefits, the nasal cavity presents a highly complex biological environment. Mucociliary clearance, enzymatic activity, and anatomical barriers can quickly remove or degrade drug formulations, creating only a brief window for absorption. Achieving successful intranasal delivery therefore requires careful optimisation of formulation properties (such as viscosity, pH, and excipient selection), informed device choice, robust nasal spray or powder performance testing, and precise deposition targeting. These elements must be supported by rigorous analytical characterisation, regulatory‑aligned quality assessments, and GMP manufacturing to ensure safety, efficacy, and consistent delivery to the intended nasal region.  

Why partner with Intertek as your nasal drug development and testing partner?

Intertek offers uniquely integrated nasal product development support from early formulation through clinical‑ready manufacturing for all types of nasal drug delivery system. Our experts combine deep scientific knowledge of nasal physiology with extensive experience in formulation development, nasal drug delivery device performance testing, analytical characterisation, and regulatory‑aligned in vitro bioequivalence (IVBE) studies.

End-to-end nasal system development services: Integrated services covering formulation development, analytical testing, device selection and compatibility, stability studies, nasal drug product clinical trial manufacturing, and regulatory CMC support.

Specialist expertise: Over 35 years of experience developing nasal drug products and complex respiratory delivery systems, including multidose aqueous sprays, monodose and dry-powder devices, pressurised-based nasal sprays and nasal liquid drops.

GMP-compliant analytical laboratories: Regularly inspected by major regulatory authorities (e.g., MHRA and FDA), ensuring high-quality data suitable for global submissions.

Cutting-edge analytical instrumentation: Comprehensive nasal spray and powder testing to ensure consistent and effective nasal administration – including spray content uniformity, device delivery, spray pattern, plume geometry, droplet size, laser diffraction, high-speed imaging and MDRS particle identification to characterise nasal drug performance.

Advanced in-vitro performance testing for nasal sprays and aerosols: Expertise across nasal solutions, suspensions, and powders, providing robust droplet/particle size distribution, spray pattern, plume geometry, and dose uniformity assessments.

Integrated formulation-device evaluation: Support to optimise intranasal drug delivery systems and ensure compatibility between formulations and device components.

Regulatory-ready product characterisation: Including extractables and leachables studies, device verification, and in‑use testing.

In-vitro bioequivalence (IVBE) studies for generic nasal products: Testing design to support submissions and to potentially reduce the need for clinical endpoint studies.

Support for both small molecules and biologics:  Experience with nasal vaccines, biologics, and advanced approaches such as nose‑to‑brain delivery.

Full lifecycle support from early development to clinical manufacturing: From early formulation and scale‑up through stability programs and GMP clinical supply manufacturing.

Deep understanding of nasal drug delivery challenges: Including mucociliary clearance, permeability barriers, and deposition targeting within the nasal cavity.

Advanced Development for Nasal Formulations and Delivery Systems

Intranasal drug delivery encompasses a wide range of dosage forms — including aqueous solutions and suspensions, nasal powder delivery, and pressurised formulations, paired with an equally diverse selection of nasal delivery devices. Our formulation team designs tailored strategies to meet the specific needs of each product, from excipient selection and device compatibility to optimisation of deposition and bioavailability. We focus on enhancing residence time within the nasal cavity through approaches such as bioadhesive polymers, viscosity modifiers, and other strategies that help slow mucociliary clearance and increase the amount of drug or vaccine delivered to the target region.

A key consideration for the formulation of nasal spray products is maximising absorption across the nasal mucosa. We employ a range of techniques to improve permeability and solubility, including the use of surfactants, permeability enhancers, and solubilising excipients. Ingredients such as polysorbates or lecithin, for example, can improve the solubility and membrane transport of certain APIs, supporting more efficient intranasal delivery.

Our integrated approach ensures that nasal spray formulations, powder systems, and other intranasal products are optimised for performance, stability, patient usability, and regulatory compliance - helping you advance your nasal drug product with confidence.

Stability Testing Excellence for Nasal Sprays and Intranasal Delivery Systems

Stability is a critical component of nasal drug formulation development, ensuring that intranasal products maintain their quality, performance, and safety throughout their shelf life. Nasal sprays, suspensions, powders, and pressurised systems can be particularly sensitive to changes in viscosity, pH, droplet or particle size, device performance, and microbial integrity -making robust stability assessment essential for regulatory approval and reliable patient use.

We provide comprehensive stability study support for nasal drug products across all formulation types, including aqueous sprays, suspensions, dry powders, and nasal spray devices. As home to one of the largest ICH stability facilities in the EU - with 625,000L controlled stability storage covering a wide range of temperature and humidity conditions - we offer extensive capacity for both long‑term and accelerated studies.

Our integrated approach includes protocol design, method establishment, study management, sample analysis and reporting ensures that nasal spray formulations, powder systems, and other intranasal products are optimised for performance, stability, patient usability, and regulatory compliance — helping you advance your nasal drug product with confidence.

Optimising Nasal Drug Delivery Through Smart Device Selection

Selecting the right nasal delivery device is fundamental to achieving consistent, effective intranasal drug delivery. Device–formulation compatibility plays a critical role in ensuring dose accuracy, spray performance, patient usability, and overall product reliability. With multiple platform options available — including aqueous sprays, dry powders, and propellant‑based systems, identifying the optimal device can be complex and highly product‑specific.

At Intertek, we take an independent, science‑driven approach to nasal device selection. As we are not tied to proprietary device or formulation technologies, we can objectively evaluate the full landscape of delivery options and identify the most suitable device–formulation combination for your program. We provide comprehensive support as outlined in the CMC guidance such as the EMA Guideline on the pharmaceutical quality of inhalation and nasal medicinal products (effective from February 2026).  Our expertise includes:

• Patient in-use and misuse studies
• Device verification testing
• Cleaning studies
• Dosing to exhaustion assessments
• Extractables and leachables (E&L) evaluations

Our team has decades of experience in understanding how polymers, elastomers, and plastics interact with nasal formulations, and how these materials may degrade over time. We assess device usability, reliability, and dose consistency across the full product lifecycle, ensuring accurate metering and robust performance — particularly for multidose nasal spray systems.

Advanced Nasal Spray Testing & Product Characterisation

Nasal sprays (and most nasal aerosols) typically produce droplets in the range 20-200 microns, with a small fraction of fine droplets below 10 microns that must be accurately quantified. To support this, we perform droplet and particle size distribution testing, as well as spray pattern and plume geometry assessment using industry-standard, validated techniques such as cascade impaction, laser diffraction and high-speed laser imaging.

For nasal suspensions, we apply Morphologically‑Directed Raman Spectroscopy (MDRS) to directly measure API particle size with precise chemical identification of both drug and excipients. MDRS has become a critical tool in generic nasal suspension development, where demonstrating equivalence to the reference product may reduce the need for clinical pharmacokinetic endpoint studies.

Our laboratories also characterise key physicochemical properties — including viscosity, aqueous solubility, and pH, and quantify visible and sub-visible particulates via light obscuration, electron microscopy and other microscope-based techniques. We continually invest in state‑of‑the‑art instrumentation to support comprehensive nasal product characterisation, including:

• Proveris SprayView system for spray pattern,plume geometry, spray velocity
• Proveris Vereo automated actuators
• Malvern Spraytec Laser particle and droplet sizing distribution
• InnovaSystems automated actuators
• Malvern Morphologi M4-ID with MDRS
• Next Generation Impactor (NGI) and Andersen Cascade Impactor (ACI) for analysis of drug in small droplets/particles (DISP)
• Various spray content uniformity / emitted dose apparatus
• Electronic rotational viscometers (Brookfield)
• Nasal Drug Product Stability and Device Compatability
  
  

GMP Nasal Formulation Scale-up & Clinical Supply

Our GMP clinical manufacturing capabilities support the seamless transition of nasal drug products from development into clinical evaluation. We provide end‑to‑end manufacturing services for a wide range of intranasal formulations, including aqueous nasal sprays, suspensions, dry powders, and propellant‑based systems.

Our GMP facilities are equipped for small‑scale and pilot‑scale production, enabling efficient scale‑up from laboratory batches to clinical trial supply. We offer precision nasal spray filling, device assembly, and packaging under controlled conditions to ensure product quality, consistency, and regulatory compliance.

Our clinical manufacturing services include:

• GMP production of nasal sprays, suspensions, and powder formulations.
• Nasal spray filling and device assembly.
• Scale-up from development to clinical batch sizes.
• Clinical trial supports manufacturing and packaging.
• Batch release testing and quality control.
• Stability program support and storage.
• Device-formulation compatibility assessments.

With integrated analytical testing, formulation expertise, and GMP manufacturing under one roof, we ensure your nasal drug product is manufactured to the highest standards and ready for successful clinical evaluation.

Regulatory Pathway Support for Nasal Drug Development

Navigating the regulatory landscape for nasal drug products requires a detailed understanding of evolving global expectations, particularly around device–formulation integration, product performance, and in‑vitro bioequivalence. Our Regulatory and CMC experts provide strategic guidance throughout development to ensure your nasal spray, suspension, or powder product meets the requirements of regulatory agencies.

We provide strategic guidance aligned with FDA, EMA, and ICH expectations, including the EMA Guideline on the Pharmaceutical Quality of Inhalation and Nasal Medicinal Products (effective February 2026). Our team helps you anticipate regulatory expectations, mitigate risk, and build a robust data package that demonstrates product quality, safety, and performance.

We offer fully integrated IVBE study packages to help accelerate the development of generic nasal sprays and powders. From device performance and formulation characterisation to deposition testing and comparative quality assessments, our services provide the robust data needed to demonstrate bioequivalence and support successful regulatory submissions. All studies are conducted under regulatory‑aligned protocols to support required submissions.

Our Regulatory & CMC support includes:

• CMC strategy development for nasal drug products
• Guidance on formulation–device integration and performance requirements
• Support for IVBE study design and justification for generics
• Preparation and review of CMC sections for regulatory submissions
• Regulatory gap assessments and risk mitigation planning
• Support for lifecycle management and post‑approval changes
  
  

Accelerate your nasal drug development journey

Take the next step in accelerating your nasal drug development services with our expert team. We provide fully integrated support — from formulation development and nasal spray performance testing to GMP manufacturing, scale‑up, and clinical trial material production. Our nasal drug delivery experts help you optimise delivery, enhance product performance, and ensure regulatory‑ready quality throughout development.

Whether you are developing an innovative intranasal therapy or a generic nasal spray, we offer the scientific, analytical, and manufacturing expertise needed to bring safe, effective nasal medicines to market. Contact us to discuss how we can support your program and help you achieve reliable, patient‑focused intranasal delivery.