Intimate Care
Despite all the progress and advances in science, women’s health still remains an underrepresented, understudied, or a topic simply ignored. It’s time to take women’s health seriously! One of the ways to address this is by providing women and healthcare providers the best available tools and information to facilitate diagnosis and treatment of conditions related to women’s health. At Nemera, with our ‘Intimate Care’ offering we bring vaginal applicators dedicated to women.
Women are exposed to various intimate pathologies such as:
- Vaginal candidiasis
- Bacterial vaginosis
- Vaginal atrophy
- Hemorroids and anal fissures
Our 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
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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 oral, vaginal and rectal treatments such as Oral infections, Vaginal infections, and Rectal diseases.
There are different types of vaginal infections:
• Bacterial vaginosis
• Vaginal candidiasis
• Trichomoniasis
Our applicators target 2 main treatments:
• Hemorrhoids
• Anal fissure
