The group obtains excellent results in the recent maximum audits that allow it to go further in proposing innovative solutions to its clients.
NutraResearch has been authorized to develop medical devices. These are products that can prove favorable for the treatment of some symptoms due to their physical effect without pharmacological action, unlike food supplements in which it is not possible to indicate any action. This is how, for example, a sanitary product can incorporate on its label “Indicated for the relief of cough”.
The development of this type of product requires compliance with regulations that are closer to the standards of the pharmaceutical sector and stricter than those governing food supplements. Precisely, NutraResearch has obtained excellent results in the recent audits that have led to this authorization.
How has NutraResearch obtained this extraordinary evaluation?
The group has developed and produced a medical device for a customer. In order to validate the development and commercial process of the new product, the Spanish Medicines Agency (AEMPS) thoroughly examined all the processes followed and made sure that the group’s production plant, located in Barberà del Vallès, has all the necessary skills. This audit was carried out on maximums, that is, under the most demanding application standards possible. This allows NutraResearch to expand the development and production of new and innovative medical device products.
In addition to the AEMPS visit, the notifying body of the country of registration, in this case Italy, audited the Barberà facilities, successfully passing said audit, in which few companies in the sector are authorized.
At the same time, the group has been subject to the annual follow-up audit of food GMPs. This periodic audit is responsible for reassessing all processes related to the company’s activity. “The people responsible for the GMP audits congratulated us on the great robustness of our entire system”, highlights Javier Sala, from the R&D department.
“At NutraResearch we always approach audits as an opportunity for improvement. The fact that we have approved them with such good marks makes us proud, because it is a demonstration of the total reliability and high quality of our manufacturing system”, says NutraResearch’ CEO, Gemma Casadevall.
For the entire NutraResearch group, both in its development and production area, defined by its full innovative character and the contribution of new solutions, a world of new possibilities opens up in new markets and for new customers: “We can develop more complex and respond to new requirements. Our plant is prepared to carry out a broader activity around medical devices. All of this with the full confidence that we have the highest quality standards, as confirmed by the audits”, says Casadevall.