Your advantage
- Compliance with current EU regulatory requirements (e.g. SmPC Guideline, QRD templates/requirements, Standard Terms, MedDRA terminology, Readability Guidelines)
- New products that can get on the market faster by optimizing opportunity for first-round approvals
- Existing products that stay on the market, as they are compliant and supported by correct labeling
- Attain approvals for new markets by developing compliant labeling for new geographies
- Our translations received excellent ratings from EMEA (translation quality ratings are issued on EMEA Form 1)
- Your product labeling is taken care by an expert team with long-standing regulatory, scientific plus linguistic, and work-art expertise throughout the whole MAA procedure
- Seamless, comprehensive labeling services; no need to manage multiple vendors
- User-tested labeling that helps optimize physician and patient understanding of instructions in the package leaflet
- Close cooperation with the client, tailored task assignment possible
- All issues regarding Product Information texts, including set-up, Language Service and Harmonization of PILs can be addressed
