Biotechnology Translation
Accurate, efficient biotechnology translations by an industry-leading expert
To successfully launch a new product, today’s biotechnology companies must be prepared to communicate and collaborate in an increasingly global marketplace. Timing is critical. No one can afford to risk costly delays in translating and reviewing the clinical research, regulatory submission, production and marketing documents needed to bring their product to market.
Merrill Brink International specializes in biotechnology translation services for biotechnology firms. Our quality-driven translations and rapid turnaround times can help streamline the process. We can ensure that your global marketing campaign is delivered on time, in an accurate and culturally sensitive way.
Proven subject matter experts for biotechnology translations
A leading provider of biotechnology translations with more than 30 years’ experience, Merrill Brink has helped many companies with the translation, localization and formatting of thousands of documents and other content, including:
- Clinical trials: PROs, protocols & protocol synopsis, investigator’s brochure, ethics committee letters, patient information, ICFs, labels, CRFs, pharmacy manuals
- Regulatory affairs: SmPCs, product labeling, package inserts, CTDs, eCTDs, protocols, PILs
- Manufacturing: Datasheets, certificates of analysis, SOPs, validation documentation, batch manufacturing records, DFUs
- Legal documentation: Clinical trial contracts, insurance policies & certificates, employment contracts, trademark documents, patents, patent disputes, government decrees
- Marketing communications: Web sites, press releases, presentations, brochures, executive speeches, newsletters, media clips
- And also: PIM, training manuals, eLearning and user manuals
Merrill Brink’s specialized linguists have pharmaceutical, biotechnology and scientific subject-matter expertise. Your projects are managed by professional, customer service-committed project managers with years of quality and risk management experience.
Unmatched quality assurance and risk analysis
Merrill Brink is one of the few biotechnology translation service providers in the world to meet a variety of international quality standards. Our commitment to these rigorous standards means you never need to worry about the safety and security of all of your translation materials.
Merrill Brink has proven experience with international business and regulatory standards such as:
| • FDA regulatory programs | • European Union Directives: |
| • Japanese Pharmaceutical Affairs Law (PAL) | o Medical Device Directive 93/42/EEC (MDD) |
| • ISO quality and risk management standards | o In Vitro Diagnostic Medical Device Directive 98/79/EEC (IVDD) |
| • CE Mark requirements | o Active Implantable Medical Device Directive 90/385/EEC (AIMDD) |
| o Directive 2004/27/EC concerning human medicines |
Proven, reliable biotechnology translation services
When you need a biotechnology translation service provider who understands the precision, adherence to deadlines and risk management requirements of the biotechnology industry, choose the industry leader – Merrill Brink International.