The growing prevalence of chronic diseases, along with the evolution of self-administration at home, is driving new ways of administrating parenteral drugs. As injecting a drug means increased risks of use errors and needlestick injuries, self-administration at home translates into a need for safer, easy-to-use and ergonomic devices.
We are committed to ensure adherence and user well-being for patients and healthcare professionals providing a comprehensive parenteral product range that matches their need.
Our premium passive safety device platform, Safe’n’Sound®, helps in preventing needlestick injuries and leveraging patients’ injection experience. It is ergonomically designed for both skilled and inexperienced users.
Safe'n'Sound® 1ml Safe'n'Sound® 2.25 ml
Our comprehensive portfolio of own-IP and tailor-made pen injectors help customers to treat a wide range of pathologies.
Reusable pens Disposable pens Tailor-made pens and autoinjectors
We developed a portfolio of devices to deliver implants with integrated needlestick protection. As implants can vary a lot, we support your projects and explore design attributes which will increase the user experience such as improved holding and priming, improved motion for implant insertion, etc.
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Nemera’s wearables: a unique on-body injector offering, to improve patients’ injection experience.
Discover MoreOur 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
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
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
Subcutaneous injection is a highly effective route to administer various drug types including small molecules and biologic drugs.
Our parenteral device range is used to treat patients with hormonal disorders such as diabetes and infertility. Besides, patients with other chronic conditions such as immune disorders could also benefit safety coupled with an enhanced injection experience from using our devices.
The safety mechanism in an active safety system needs to be activated manually by users.
On the other hand, a passive safety system does not require users to do any additional steps to activate the safety mechanism to prevent accidental needlesticks, hence is a more user-friendly device.
Pen injectors typically use a cartridge system coupled with a multidose formulation. Disposable pen injectors come ready to use, with a set amount of drug available in a cartridge (prefilled pen). Prefilled pens are disposed of when the drug in the cartridge is depleted.
A reusable pen injector contains a replaceable cartridge with medicine inside. Once the cartridge is empty it can be discarded and replaced with a new one. Reusable pens are meant to be used for an extended period of time, allowing the patient to use the same device even for several years.
Although diabetes account for vast majority of total pen volumes worldwide other therapeutic areas are growing. Outside insulin and GLP-1 administration sector, systemic hormones and fertility cover the largest segment. In general pen injectors usually use a cartridge system for a multidose formulation, making them potentially suitable for any drug available in a cartridge.
With an in-depth analysis of the intended use, preferences of the target group as well as needs, expectations and limitations of patients, our product platforms offer a range of injection devices, for an administration of a wide range of pharmaceutical products, including insulin pen injectors (for human, glargine, lispro, aspart), somatropin pen injectors, follistim pen injectors, teriparatide pen injectors, exenatide pen injectors, pramlintide pen injectors and liraglutide pen injectors.
With a growing tendency of self-administration at home, patients wish for independence and confidence in taking their medications with safety. In line with this, drug regimen is switching from intravenous to subcutaneous route to facilitate self-administration without healthcare professional’s intervention. Besides, new molecules are being developed and injecting a high viscous biologic formulation could be challenging.
Our robust, easy-to-use on-body injector device answers these growing needs and helps reaching seamless delivery with safety and comfort.
Cutting-edge insights, resources, press articles, and webinars to learn more about the holistic ecosystem of drug delivery device solutions.
Discover moreWe 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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