Services for the hi-tech industry
- Regulation, validation, and verification services for organizations, large business, and startup companies at the development stage.
- Development of a regulatory strategy throughout product’s lifecycle for startup companies.
- Consultation with international regulators and document submission to FDA, Notified Bodies and other competent authorities.
- Planning, writing, and evaluation of regulatory submissions of pharmaceuticals and medical devices: CE, FDA, PMA, K510, A Mark Technical Profile, The Canadian Ministry of Health, The Israeli Ministry of Health, and East Asia. Including CER Biological Safety Reports and more.
- Regulatory support and technical guidance during the R&D process.
- Periodic audit of new standards that are relevant to each product.
- Implementation & application of testing standards during product characterization process.
- Writing, editing, support, and submission of pre-clinical and clinical trials documents, such as: researcher’s manual, research protocol, agreement forms, etc.
- Clinical test monitoring of medical devices for medical institutions and companies