EU Dossier, CRO
- Clinical & Non-clinical EU Experts (M2, M4 & M5 writing/compilations/reviews)
- Quality EU Experts (QOS writing & M3 reviews)
- BE and Clinical Studies - full CRO services in EU
- Dossier Development and Compilations
- CTD Dossier development, writing, reformatting, compilation, GAP analyses and/or reviews
- Preparation of Non-Clinical and Clinical Overviews and Summaries
- Preparation of QOS - Quality Overall Summaries
- BE and Clinical Studies - full CRO services in EU
- Readability testing (RUT)
- Providing a specialist readability testing service to ensure compliance of patient information leaflets (PIL) for drugs and other medicinal products, using the latest version of the QRD templates and that it follows MedDRA and EDQM terminology.
- Performing the Readability test according to EU regulations, carried out by an experienced interviewer with good interview, observational and listening skills.
- All phase included (pre-assessment of concerned PIL, recruiting participants, preparing protocols and questionnaires, conducting pilot and full test, evaluation and reports with test details).
SPC, PIL, LABELLING
- creating Summary of Product Characteristics (SmPC),
- Patient instructions leaflets (PIL)
- Labelling with Artworks in local languages, in accordance with relevant applicable guidelines.
Electronic dossier compilation, publishing and electronic submissions (EU NeeS, CTD, eCTD)
- SCIENTIFIC TRANSLATION SERVICES FOR ENGLISH LANGUAGE
- Professional medical translation services from local languages to English language and vice versa
- Verifications and legalizations of translated documents in WBC, Cyprus, Bulgaria, Romania, Croatia, Slovenia, etc.
