Multidose Pump Systems
We offer various technologies with a full range of pump and valve platforms.
SP270+ and SP370+ SP27 and SP37 In-vitro Bioequivalence for nasal sprays Child Resistant solutionsEar Nose Throat (ENT)
Make every spray count
The number of drugs delivered through the ear, nose and throat is expanding.
We provide a comprehensive range of pumps, compatible with a wide choice of actuators for each delivery route (ear, nose and throat), suitable for regulated and low regulated markets.
We guarantee precision and dose consistency to maximize treatment efficacy and improve patients’ outcomes.
UniSpray
Unispray delivers one single-metered accurate dose, ideal for systemic delivery for emergency lifesaving and crisis treatment.
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Nasal Vaccine
Our nasal vaccine concept device is currently under development, ideally used for respiratory infections prevention such as covid-19, influenza amongst others.
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Electronic technologies
Thanks to our Electronic know-how and our capabilities to answer patients’ needs, we offer a full range of services for design, development and manufacturing of electronic devices for nasal delivery.
Safe'n'Spray Electronic Nasal deviceOur integrated combination product services
ANALYTICAL SERVICES & DESIGN VERIFICATION
Our team of experts is dedicated to ensuring the safety, efficacy, and compliance of your combination product including:
• Comprehensive analytical services and design verification
• Advanced testing methods tailored to your formulation and active ingredients
• Testing method development, administration, and reporting
• Performance and integrity verification of your device and drug product
• Adherence to global standards throughout the process
HUMAN FACTORS & USER EXPERIENCE MANAGEMENT
We provide exceptional support for combination products across diverse regulatory pathways, device types, and patient populations for global markets including:
• Human Factors program strategy and risk management
• Formative/summative testing (design validation) administration
• Human Factors Enginering documentation for regulatory submissions
• Enhances safety, usability, and overall satisfaction of your combination product.
• Aligns with FDA Human Factors Engineering guidelines and ISO 62366 standards
• Extends beyond the device to include instructions for use, packaging, and training programs to optimize user adherence and engagement
REGULATORY STRATEGY & SUBMISSION AUTHORING
We provide tailored strategies and support for all stages of the regulatory process, including:
• Development of a comprehensive regulatory strategy including premarket to post-market support
• Guidance on FDA regulations and international standards (ISO 14971, ISO 10993)
• Expert support in regional regulatory guidelines
• Assistance in authoring and compiling regulatory submissions, including: Premarket Approval (PMA), 510(k) submissions, CE marking documentation, and Notified body opinion support
• Accelerated submission processes, drawing from, our experience in over 54 markets
FAQ
Intranasal delivery is a common route of administration for treating various indications, from allergic rhinitis to breakthrough cancer pain (fast-acting pain control by nasal spray).
Nasal delivery is an attractive option for locally acting medications (e.g. saline solutions, decongestants, corticosteroids or antihistamines) which treat allergic rhinitis and nasal congestion.
More drugs targeting other therapeutic fields and diseases may join the increasing ranks of marketed products for systemic delivery using the nasal route, which may vary from benign to serious health condition.
The nasal route is not invasive and does not require healthcare professionals’ intervention where patients can self-administer their remedy with a rapid onset.
Besides, it allows better bioavailability as drug administration via the nasal route avoids hepatic first-pass effect which could be encountered when taking medications orally.
Bioequivalence for nasal spray is a prerequisite for all generic applications.
Depending on the countries (in Europe) it can allow pharmaceutical companies to waive in-vivo clinical studies. For USA, the current expectation is to have in-vitro and in-vivo BE studies.
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Our services
End-to-end services and expertise in device development, device consulting, and contract manufacturing to complement our diverse portfolio of products and to help you through every step of the journey.
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Cutting-edge insights, resources, press articles, and webinars to learn more about the holistic ecosystem of drug delivery device solutions.
Discover moreWho we are
We design and manufacture devices that maximize treatment efficacy and partner with our customers in their device strategies, to ultimately bring high-quality and safe treatment solutions to patients.
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