We are here for you every step of the way. With our support and advice, you can be confident of meeting your regulatory requirements right from the start.
We provide regulatory consulting for medical devices and other healthcare companies. Solving regulatory issues often requires considerable time and resources. BioReg’s strategic advantage is its ability to identify easy and often innovative solutions within the regulatory milieu. We examine all potential regulatory avenues available to clients to determine and develop the most beneficial product strategies in each case.
Our expertise covers various industries and products, including Medical devices, AI & Software, Digital Health, Biologicals, Combination products, Pharmaceuticals, Protective equipment, General Wellness devices, Veterinary products, Cosmetics, Food supplements, Homeopathic drugs and Cannabis products.
BioReg regulatory services include, among others:
- Strategic advice & gap analysis (MDR, FDA, Israel, others)
- Analysis of regulatory frameworks & requirements
- Writing clinical protocols & clinical evaluations
- Post-market Surveillance (PMS) & PMCF plans
- Preparation of regulatory submissions
- Building Quality Management Systems
For more information, don’t hesitate to contact BioReg team.
In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.