RS NESS Engineering provides an umbrella of services for your ongoing operations, establishing new facilities and infrastructure or incorporating end-to-end project activities, while adhering to the regulatory requirements. Knowledge, professionalism and dedication lead our highly qualified engineers to your success.111

RS NESS operates in the pharmaceutical, biotechnological, medical device, food & cosmetic industries.

RS NESS Engineering provides an umbrella of services for your ongoing operations, establishing new facilities and infrastructure or incorporating end-to-end project activities, while adhering to the regulatory requirements. Knowledge, professionalism and dedication lead our highly qualified engineers to your success.

RS NESS operates in the pharmaceutical, biotechnological, medical device, food & cosmetic industries.

YOUR GOAL IS

We will act as an extension of your company and will tailor make a complete and precise solution for your specific needs, taking into consideration all regulatory requirements. After gaining many years of experience in the various fields and industries, we have the knowledge and ability to communicate with your dynamic and challenging interfaces, utilizing your processes and technical language, while blending seamlessly as well as independently with your teams and suppliers.

We provide an end-to-end overall solution for ongoing operational activities and projects to small, medium and large companies that require engineering, project management, quality assurance, validations, regulatory and clinical services, as well as assistance for any specific area of the mentioned subjects. The valuable knowledge that you will receive from us will assist you also in your future operational activities as well as your business goals.

We at RS NESS will provide you the optimal solution for your needs

OUR SERVICES

Good engineering is at the basis of any successful operation of any device or system. We at RS NESS bring to you our vast knowledge and professionalism as highly qualified engineers in every step of the way

Every step in a project contributes to its success, therefore we take into account
each and every factor that is
part of the project
or influences it

In R&D, QA is the last frontier before production and live operation, and should be done with full attention to details along with viewing the full picture, and as a flawless and precise process

Good engineering is at the basis of any successful operation of any device or system. We at RS NESS bring to you our vast knowledge and professionalism as highly qualified engineers in every step of the way

Every step in a project contributes to its success, therefore we take into account
each and every factor that is
part of the project
or influences it

In R&D, QA is the last frontier before production and live operation, and should be done with full attention to details along with viewing the full picture, and as a flawless and precise process

A validation process includes planning and execution of testing processes to ensure that the equipment / process met the regulatory requirements, as well as the different definitions of the customer’s requirements

Knowledge and expertise in regulatory and clinical affairs is essential for any company in the pharmaceutical, biotechnological, medical devices and
food industries

Every successful task starts with planning and documenting the procedures that should be carries out. Working according to procedures not only prevents mistakes,
it creates order 
 

A validation process includes planning and execution of testing processes to ensure that the equipment / process met the regulatory requirements, as well as the different definitions of the customer’s requirements

Knowledge and expertise in regulatory and clinical affairs is essential for any company in the pharmaceutical, biotechnological, medical devices and
food industries

Every successful task starts with planning and documenting the procedures that should be carries out. Working according to procedures not only prevents mistakes,
it creates order 
 

About RS NESS

RS NESS Engineering Quality & Validation Solutions was founded in 2014 following many years of experience of its management and team of engineers.

We plan, manage and execute end to end projects and ongoing activities using our vast experienced and highly qualified and professional engineers. During this process we advise, assist in choosing the right equipment and suppliers and provide our customers with consulting and valuable knowledge, with a business vision and with compliance to all regulatory requirements.

Our Team consists of about 20 engineers (mechanical, biopharmaceutical, chemical, material & industrial B.sc) who are all certified and experienced experts.

Management

Rafi Shavit

Founder & CEO

Rafi has 17 years of experience in the pharmaceutical, biotech and renewable energy industries, and has vast experience in large scale project and processes in
the largest companies.

Zohar Zehavi

VP operations & Business Development

Zohar Zehavi has many years of experience in the pharmaceutical industry (13 years in Teva) and specializes in pharmaceutical processes, procedures,
projects management and operational excellence.

Gabriel Salmon

VP of Quality Assurance,RA and CA

Gabriel has over 15 years of experience in quality assurance, regulatory and clinical affairs fields. His experience covers pharmaceutical, medical devices, biologics and combination
product companies.

Our experts have high engineering and supervision abilities, as well as knowledge of standards and health authority regulations, required for your projects success and ensuring successful regulatory approval.

We strive to achieve the highest confidence and reliability while incorporating quality and efficiency for your best interests. We don’t just manage projects, we provide a deep understanding of all aspects in the product lifecycle, technically and business wise, using the right tools and most innovative and efficient methods and we will advise you on the items to put an emphasis on when planning, developing and deploying your products and projects.

As part of our enhanced services we provide:

  • Characterization of your solution
  • Creating all project documentation
  • Creating a detailed professional validation master plan
  • Choosing the right suppliers and performing the negotiations
  • Choosing and deploying the required infrastructure, facilities and equipment
  • Methods and procedures definition
  • Deployment of required regulations
  • Project planning, management and tracking
  • Statuses, reports and measurements
  • All types of Validations
  • Quality Assurance (establishing, managing and controlling QMS)
  • Regulatory affairs capabilities, including submission preparations and management
  • Gap analysis required for regulatory reviews and audits
  • Clinical affairs management, including clinical documentation writing, CRA

From our variety of customers

Contact Us

Contact us and we will be happy to meet and assist you with your needs