Regulatory Affairs

Knowledge and expertise in regulatory affairs (RA) is essential for any company in the pharmaceutical, biotechnologies, medical devices, medical cannabis and food industries. RA plays a major role in many considerations required during the initial phase of any company. Regulatory affairs is essential to be part of the design stages as well as throughout the entire product/software lifecycle. Being able to understand the ever growing, stricter, regulatory and clinical requirements is one of our specialties in R.S NESS Group. It is our policy to 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.

Amongst our service you can find many of the basic and essential services, as well as ongoing and improvement/remediation projects, belonging to the fields of Digital Health (SaMD) products, Combination products, MD and IVD, Pharmaceuticals and Medical Cannabis. These services include, but are not limited to:

• Regulatory strategy per product and business plan
• Performing assessment per applicable standards and Regulations that the company must 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
• Training/Coaching of regulatory related subjects