Sof’Bag®+
Sof’Bag+ is an airless pouch-in-bottle packaging solution for prescription (Rx) and over-the-counter (OTC) formulations for dermal and transdermal application.
Discover MoreDermal
Convenient for patients, protective for formulations
The dermal application is a convenient non-invasive way to administer liquid sprays, lotions, gels, or creams to the skin for dermatological, anti-inflammatory or systemic treatments.
Our airless and atmospheric delivery devices are suitable for RX and OTC formulations and have all the documentation needed to be registered on regulated markets.
Sof’Airless XS+
Sof’Airless XS+ is a protective mini-airless system to deliver gel and creams for small dose applications and sampling.
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Spray pumps for liquid formulations
We provide a wide range of atmospheric pumps to deliver your liquid and viscous formulations in a comprehensive range of doses.
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(CRC) Child Resistant Closure for dermal devices
The Child Resistant Closure for Sof’Bag® is a ‘press and turn’ concept developed to prevent unwanted child opening while making it easy to manipulate for adults.
Discover MoreOur 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
More about Nemera
Knowledge Hub
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.
Discover moreFAQ
Our systems aim to be used for all diseases for which the treatments can be administered via the skin:
- Hormonal disorders (hypogonadisms or menopausal symptoms)
- Psoriasis, an autoimmune disease that causes inflammation in the body, consisting of red, scaly plaques occurring most commonly on the elbows, knees, scalp, and lower back, but any skin surface can be involved. Psoriasis is estimated to affect 2–4% of the population of the western world.
- Eczema, a common chronic or recurrent inflammatory skin disease characterized by acute flare-ups of eczematous pruritic lesions over dry skin. It affects 15-20% of children and 1-3% of adults worldwide.
- Acne, a common chronic skin disease involving blackheads or whiteheads, pimples, oily skin, and possible scarring. Acne is estimated to affect 9.4% of the global population, making it the eighth-most prevalent disease worldwide.
- Hair loss.
- Topical pain, like painful muscles or joints.
Given most of these treatments are self-administered by the patient, convenience such as 360-degree usage and safety are important criteria to increase compliance rates.
An airless system is a drug delivery system dispensing the formulation without air intake. Different technology based on a pump exist.
At Nemera we propose pouch-in-bottle or piston-based systems.
Airless technology protects formulations (even the most sensitive ones) from oxygen, light and moisture.
This technology allows patients to use the devices in any position. Moreover, the package has an excellent restitution rate for optimal use of the product and minimized waste.
In the pouch-in-bottle technology, the formulation is dispensed out of a collapsing pouch encased inside a rigid bottle. By activating the pump, the formulation is extracted from the pouch and air only.
In the piston technology, when the formulation is dispensed the bottom piston rises.
In both technologies, no air enters in contact with the formulation.
