We undertake the writing of Expert Reports for submission to the Regulatory Authorities. These reports include:
- Modules 2.4, 2.5, 2.6, 2.7, 4, 5 of the dossier
- Addendum to the Clinical Overview and the Non-Clinical Overview (where necessary)
- Environmental Risk Assessment Reports
- Toxicology assessments of excipients or impurities
- Determination of Permitted Daily Exposure (PDE) to establish safe exposure limits in manufacturing shared facilities according to EMA “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities” (EMA/CHMP/ CVMP/ SWP/169430/2012). (A seminar for in-house training of QA departments is also available)
All reports are in accordance with EMA guidelines and are signed by an Expert and accompanied by his/her CV. In addition, all reports are delivered along with the full-text copies of their literature references.
Compilation/Amendment of Product Information (SmPC, PIL)
We undertake the compilation or amendment of Product Information (Summary of Product Characteristics, Labelling & Package Leaflet) in accordance with EMA guidelines and regulations (templates, MedDRA etc.)
Readability Testing of Package Leaflets
We also undertake the conduct of Readability Testing (User Testing) of Package Leaflets.
Each Package Leaflet is studied separately and the testing is conducted after taking into account the indications and all other data with regard to the specific medicinal product, with a questionnaire created exclusively for each product.
Our scientific team includes experts with long-term experience in regulatory affairs and clinical experience, thus ensuring the best possible utilization of the results in order to achieve a legible, clear and easy to use package leaflet.
We provide support for the procedure of Scientific Advice from the European Medicines Agency (EMA), and specifically, we provide consultancy and undertake the preparation of the necessary documents and presentations.
Our aim is not just a translation, but a carefully manipulated translation in accordance to the national regulatory authorities. That is why we collaborate with scientists like pharmacists, physicians, biologists etc. from all over the world, native in the target language, who work for years in the field and have a great translation experience.
And we don’t stop there: an independent proofreader is editing all of our translations.
That way, we ensure:
- The best possible use of the target language
- The best possible use of scientific terms
- The adherence to regulatory guidelines
This translates to the best possible service quality.
We undertake the writing of medical documents that effectively and explicitly present:
- Your research
- The use of your product (either for presentation to your clients or for internal training purposes)
- Other medical information
Our main target is to facilitate you by undertaking a time-consuming part of your scientific work, while maintaining the highest scientific standards.
We perform literature researches for pharmacovigilance or other purposes.
In addition, having a wide network of associates throughout Europe and access to many of the most complete libraries, such as the British library, we are able to undertake the collection of full-text articles and deliver them in hard copy or electronic format.