EU Regulatory

Affairs

We routinely translate European Medicines Agency (EMA) Marketing Authorisation Applications (MAAs) using QRD (Quality Review of Documents) templates for both human and veterinary medicinal products.

We have extensive experience in the translation of Product Information required by the EMA as part of their procedures for MAAs and Variations.

Ever since the Marketing Authorisation was introduced to Europe through the First Pharmaceutical Directive in 1965, DWL has translated product information for many of the world’s most important drugs.

Later, DWL supported the European pharmaceutical industry in tackling the linguistic and regulatory impact of the accession of new Member States, the advent of the Mutual Recognition Procedure and later the Decentralised Procedure.

Today we translate all necessary regulatory documentation relating to clinical, non-clinical and product information for the Common Technical Document (CTD) and all post-marketing authorisation variations, pharmacovigilance and pharmaco-economic documentation.

Through our association with The Organisation for Professionals in Regulatory Affairs (TOPRA), Clinical and Contract Research Association (CCRA) as well as regular attendance at regulatory events and seminars we stay ahead of an ever-changing regulatory landscape.

Centralised Procedure (CP)
Type IA/IB and Type II Variations
Mutual Recognition Procedure (MRP)
Decentralised Procedure (DCP)
Referral Procedure
ISO 9001 Certified

Non-EU Marketing Authorisation Applications involving the translation of parts of the Common Technical Document (CTD) or similar types of documentation

With the increasing amount of regulation in traditional and emerging markets, DWL’s service involves the translation of:

Regulations into English from the target market language
Documentation for submission into the target market language

In-house medical team can review English language Product Information before translation, for a smoother path to your successful MAA. DWL is involved in the translation process for MAAs on a daily basis and covers all relevant aspects of the different procedures such as:

First drafts
Rapporteur changes
CHMP opinion changes
Liaising with National Competent Authorities
Bookmarking of pdf conversions
Completion of QRD Form 2 and submission checklist

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We cannot stress enough the importance of information security. It’s extremely risky to engage with vendors who can’t demonstrate at an organizational level how they keep your content secure from Intellectual Property theft and information leaks.

We are the only language services provider that holds an independently audited SOC 2 Type 2 report on an organizational level — which goes far beyond just having super secure platforms. Our entire organization has your back to protect your information, your currency, with LanguageVault.

We foster close relationships with Regulatory Affairs Specialists in Europe to ensure that we can provide solutions to our customers in an ever-changing regulatory landscape.