Within the Medical Translation Division, our expert Regulatory Team manages marketing authorization (EMA and FDA) applications for human and veterinary medicines.
This vastly experienced team has developed robust and tightly controlled internal procedures to ensure compliance with the strict demands and time constraints of submission schedules.
Working regularly with the EMA centralised (CP), decentralised (DCP) and mutual recognition (MRP) procedures, the team delivers accurate translations that comply with the QRD templates and conventions required for each Member State. The team also manages updates following the CHMP opinion, and handles Member State comments and amendments during the linguistic review stage – a comprehensive service always delivered within the submission deadline.
We also assist companies in meeting the challenges of implementing Good Pharmacovigilance Practice (GVP) under increasingly stringent regulatory requirements, and provide accurate translations of safety data coming from multiple language sites, these translations complying with MedDRA, EMA and EDQM guidelines and terminology.
Our expertise includes:
- Adverse event reporting – e.g. SAEs and SUSARs
- Case Report Forms (CRFs)
- Common Technical Documents (CTDs)
- Correspondence from health authorities
- EMA and FDA marketing authorization applications
- Product information (SPC, PILs etc.)
- Published articles
The Regulatory Team works alongside the other specialist teams (Clinical, Medical Device, Pharma and PRO) in the Medical Translation Division so that every single language requirement of life science companies and CROs can be met.