Regulatory Affairs
What is Regulatory Affairs?
Regulatory affairs focuses on ensuring compliance with medical device regulations. Our aim is to guarantee that devices meet safety and quality standards while maintaining their effectiveness throughout their life-cycle.
Our Services
Translations management and coordination
Good product information is critical to your product. We know local languages and requirements to ensure your product information fulfills high quality standards.
Our translations are always quality controlled (QC) by following four-eyes principle, according to given timelines, including linguistic reviews, updates, and inclusion of local information. Approved vendors may be used for translations, QC by our own staff is always included in service.
We translate all product related, or process related documents, such as product information texts of various products, medicines, food supplements, medical devices, cosmetics. We translate also marketing materials, medical information questions, Adverse event reports, complaints, safety notifications, from English to local language or from local language to English.
We translate and localize your SOP’s, forms, trackers or other documents for PV, GDP, GMP among others.
In case of localisation of text in addition to translation; local requirements of product categories are always considered.
RA Intelligence
We keep you updated on local legislation changes, but in addition to that, you will be provided with news, and hints of coming changes in our territory. Feel free to choose product categories (Medicines, food supplements, medical devices, cosmetics), types of news PV, RA, GMP, GDP, clinical trials) and we will provide to you a monthly overview of what is going on.
Training
We ensure your message goes through and adjust to local requirements or responding to an expert confirmation.
Ask for annual PV, GDP refreshers, process specific trainings, such as trainings on deviations, changes controls, pharmacovigilance case management or whatever knowledge in the need to be known more.