Knowledge and expertise in regulatory and clinical affairs is essential for any company in the pharmaceutical, biotechnologies, medical devices and food industries. Regulatory and clinical affairs play a major role in many considerations that are required during the design stages, the product development cycle, when setting up the labs environments, in the production room and as part of other processes. A problem in these fields may cause rework, delays and even have irreversible business impact on the company. Being able to understand and embed the regulatory and clinical requirements is one of our specialties in RS NESS, and we will provide your company with this valuable knowledge, support your development processes and assist you with your needs, while executing negotiations and plans with the different regulatory authorities.
Following are our regulatory and clinical services:
- Strategizing the regulations that the product is required to comply with
- Leading discussions with regulatory authorities (EU competent authorities and notified bodies, FDA, ROW)
- Design and development support from a regulatory perspective, including V&V,
- Writing and managing submissions to the different authorities and medical centers, including technical files, IMOH Medical Devices, PMA, 510(k).
- Product verification strategy
- Preparation of clinical study documentation, including protocols, IB, IFU, ICF, CRF
- Site specific related management (site selection, coordinate study team, site visits, agreements, budget, insurance)