Regulatory Compliance Translation Services

To remain competitive in today’s medical industry, companies must cater to a growing number of major international markets. Each market is tightly controlled by its own regulatory and governing bodies, presenting a unique set of challenges to medical, pharmaceutical and biotech organisations. Regulations can vary significantly from market to market. They are incredibly complex and require the strictest compliance, as failure to meet the prescribed standards can incur costly legal penalties and prevent companies from accessing major markets entirely. There is simply no room for error.
 
Our services in this field
With such high stakes, using a standard translation service is a risk that no medical organisation can afford to take. Medical compliance translation is a highly specialised discipline requiring years of experience in international regulatory compliance, and a solid understanding of the nuances between markets. 
 
DOCUMENTS WE COMMONLY TRANSLATE:
Approval dossiers Translation
Summary of product characteristics  Translation
Packaging and inserts  Translation
Labelling Translation
Validation protocols
Patient information leaflets Translation
Instructions for use Translation
Clinical trial documentation Translation
Informed consent forms Translation
Case report forms Translation
Risk assessments Translation
Biocompatibility reports Translation
Manufacturing procedures Translation