Oral Administration

We are delivering oral drug delivery devices for:

  • Pediatric – analgesic non-narcotic and anti-acid & anti-flatulent
  • Medical food supplementation – liquid food supplement

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

FAQ

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