Regulatory Affairs Support

LangCor Service GmbH supports regulatory departments and regulatory affairs service providers with specialised services concerning pharmaceutical product information.

Our Services

• Specialist translations of product information (SmPC/PL and label texts) in all EU languages. The services take place within the narrow time frames of MRP/DCP and CP. This service also includes full support during the linguistic review.
• QRD template updates for national procedures, MRP/DCP or CP.
• “Variation support“ – this includes services concerning product information in the context of notification of variations - e.g. comparisons, consistency checks, updates and translations.
• “Medical writing“– for product information – e.g. from CCDS to “European Core SmPC”, “Core PL” and “Core Label”, to the national level in CP, MRP/DCP and national procedures.
• QRD formatting checks – formatting of product information according to the EMA QRD formatting convention using the “LangCor QRD formatting review tools”.
• Readability user test and bridging according to the Readability Guideline.
• Adjustment to the originator text in all EU languages – creation and updating of product information on the basis of existing originator texts.
• Creation of package leaflets and patient brochures in patient-friendly language.
• QRD template seminars for regulatory affairs personnel.
• Inconsistency checks – e.g. between various strengths and Core Data Sheets and nationally approved texts in all EU languages.
• MedDRA terminology checks – Checking MedDRA terminology in Section 4.8 of your SmPCs.
• Creation of style guides for the formatting and design of product information.

Further consultancy services

• Writing for patients – Specialist knowledge expressed in simple terms for laypeople.
• Regulatory requirements for product information in the EU (advice on compliance)
• Use of software in translation and localisation processes – XML-based management of product information (PIM)
• Terminology management and translation memory systems
• Quality assurance in the language process
• European readability compliance. Analysis of large product portfolios with respect to cost-efficient bridging strategies.

Speak with us, our whole team is looking forward to your enquiry.