Your new biotech product or vaccine has to pass all phases of clinical trials before it enters the market. CLS medical translators are experts in biotechnology and, with the help of customised processes and language technologies, will ensure that your content complies with all FDA, EU and local government regulations.
CLS will deliver biotechnology writing, editing and translation projects that meet your strict scientific, regulatory and linguistic criteria. We will produce texts that meet all regulations and deadlines, whether clinical research, regulatory submission, governmental approval or marketing documents.
CLS Communication’s quality management systems have been awarded ISO 9001:2008 and EN 15038:2006 certification.
We can support you in the following text types:
- Case report forms (CRFs)
- Common Technical Documents (CTDs)
- Directions for use (DFUs)
- Electronic Common Technical Documents (eCTDs)
- Ethics committee letters
- Informed consent forms (ICFs)
- Investigator’s brochure
- Master batch records
- Package inserts
- Patient information leaflets (PILs)
- Patient reported outcomes (PROs) and questionnaires
- Protocols and protocol synopsis
- Standard operating procedure (SOP) and manufacturing process descriptions
- Structured product labelling/product information management (SPL/PIM) labelling
- Summaries of product characteristics (SPCs)