Emmace – World-Leading Testing & Advising for Inhaled Drug Products & Medical Respiratory Devices

Accelerate your path to market with Scandinavia’s premier inhalation CRO — combining
ISO 17025 accredited testing, pioneering rAPSD methodology, and deep device expertise.

Emmace provides specialized analytical testing and strategic advisory services for oral inhalation and nasal drug products (OINDPs) and medical respiratory devices.

From early formulation screening to complex ISO 18562 biocompatibility compliance and FDA/EMA regulatory dossiers, we act as your agile, extended R&D team.

Dual Analytical Service Pillars: Tailored Solutions for Pharma & MedTech

Pillar 1: Medical Device Biocompatibility (ISO 17025 Accredited Scope)

Navigate complex EU MDR and FDA 510(k) requirements for breathing gas pathways in ventilators, anesthesia systems, breathing masks, nebulizers, and heat moisture exchangers (HMEs). Our SWEDAC-accredited methods cover the updated ISO 18562:2024 standard:

ISO 18562-2 (Particulate Matter): Measurement and characterization of airborne particles (0.2 µm – 10 µm) emitted into patient breathing pathways.
ISO 18562-3 (Volatile Organic Substances): Screening and quantitative analysis of emitted VOS, including targeted analysis for aldehydes and highly reactive isocyanates.
ISO 18562-4 (Condensate Volume Determination): Precise measurement and risk evaluation of condensate formation within gas pathways.
Toxicological Risk Assessment: Expert toxicological interpretation per ISO 10993-17 and ISO/TS 21726:2019 to convert chemical characterization data into actionable regulatory submissions.

Pillar 2: Inhaler, Nebulizer & Nasal Device Testing (Pharmacopeial / Non-Accredited Scope)

Comprehensive aerosol characterization and bioequivalence testing supporting generic ANDA filings, novel formulation development, and green propellant transitions (HFA-152a, HFO-1234ze):

Cascade Impactor Testing (APSD): High-precision Next Generation Impactor (NGI) testing.
Realistic APSD (rAPSD) & Dissolution: Pioneers in innovative rAPSD methodologies and lung dose dissolution testing to accelerate formulation screening.
Delivered Dose Uniformity (DDU) & DUSA: Total emitted dose collection across device lifecycle, variable flow rates, and storage conditions.
Laser Diffraction (ISO 13320): Real-time aerosol size distribution profiling using Malvern Spraytec instrumentation.
Plume Geometry, Spray Pattern & Velocity: Non-destructive high-speed optical imaging and laser sheet visualization aligned with FDA guidance for in vitro bioequivalence (BE).
Nebulizer Testing: Delivered dose and droplet sizing utilizing cooled impactors and clinically relevant tidal breathing simulation.

Specialized Products & Advanced Aerosol Science

In addition to laboratory testing, Emmace develops advanced scientific tools and offers specialized physical characterization:

- Mimetikos Preludium™ Software: World-leading in silico modeling software for in vitro-in vivo correlation (IVIVC) and regional lung dose deposition prediction.
- Anatomical Throat Models: Standardized and customized throat models for realistic in vitro inhalation modeling.
- Advanced Physical Testing: Aerosol Mass Spectrometry (AMS) for real-time chemical tracking, Faraday Box electrostatic charge characterization, and airborne particle counting via Aerodynamic Particle Sizing (APS).

Why Leading Global Health Leaders Partner with Emmace

Niche Focus: Unlike full-service generalist CROs, we focus exclusively on inhalation and respiratory care, offering deeper scientific insight and faster problem resolution.
Scientific Authority & Regulatory Influence: Active members of standard committees (EPAG, Swedish working groups) and key academic collaborators with Lund University, University of Florida, and Malmö University.
Boutique Agility: Direct access to senior advisors with decades of Big Pharma experience — delivering fast turnaround times and transparent communication without corporate bureaucracy.
Nordic Precision: High-quality assurance, data integrity, and reliability trusted by over 200 global pharmaceutical and medical device clients.

Clear Quality Boundaries & Compliance Matrix

Parameter / Capability	Medical Device Scope (ISO 18562)	OINDP & Aerosol Testing Scope
Accreditation Status	ISO/IEC 17025:2018 Accredited (SWEDAC #10501)	Non-Accredited Analytical Service
Governing Standards	ISO 18562-2, ISO 18562-3, ISO 18562-4 (ISO 18562:2024)	European Pharmacopeia (Ph. Eur. 2.9.18), USP <601>/<1601>, ISO 27427, ISO 13320
Regulatory Drivers	EU MDR Compliance, FDA 510(k) Submissions	FDA ANDA (Bioequivalence), EMA Filings, R&D Formulation Screening
Primary Deliverables	Particulate & VOS Emission Data, Condensate Volumes, Tox Reports	APSD profiles, Delivered Dose Uniformity, Spray Pattern/Plume Geometry, IVIVC Models

Ready to Accelerate Your Respiratory Project? We are.

Discuss your project requirements directly with our senior scientific team. We will help you design a streamlined, cost-effective testing tailored to your regulatory timeline.