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As part of the approval process of a new medicine, medical device, food supplement or cosmetic product, there is a requirement to prepare a carton box, label, patient leaflet and/or physician leaflet according to the procedures.

 

Following the approval and marketing of the medicine, occasionally there is a need to change or update the information printed on the artwork. Registration holders of products belonging to the above mentioned groups are required to comply with many requirements determined by the regulator that refer to the content of the information and its placing, design (such as font size, colors), warnings, translation to other languages and more.

 

Barrco Regulatory Solutions has great experience in preparing artworks and proposes extensive services of preparing the text, professional translation to the languages: English, Arabic, Russian and native languages of other countries.

 

We work under a proven quality management system, ISO 9001:2008 IS, in order to provide you with a product that complies with the standards required by the Health Authorities, international pharmaceutical and medical device companies, manufacturers and importers.

 

It is important to us that the final product that you receive will comply with the highest criteria, whether it is the USA, European, Canadian, Australian, New Zealand or Japanese health authorities or whether it’s your own requirements or your associates requirements. We do not believe in shortcuts leading to compromise in quality. As a result, the services you receive are given by a staff that has undergone substantial training and certification, a large, experienced and professional staff that is well aware of the heavy responsibility that rests on their shoulders.

 

Barrco Regulatory Solutions understands the importance of complying with agreed upon schedules and operates an advanced project management system for achieving this goal. We are proud of working with many customers and preparing them the following, amongst other projects.