Expert Translation Services
Unlock global opportunities with our specialized translation services tailored to Pharma, Biotech, CMO/CDMO companies, as well as HCPs and Scientific Institutions.
Pharmaceutical Companies
A selection of documents we translate on a daily basis:
Regulatory and compliance documents: Standard Operating Procedures (SOPs), Good Manufacturing Practice (GMP)/Good Laboratory Practice (GLP)/Good Clinical Practice (GCP) guidelines, validation reports, and audit certificates
• Quality and manufacturing materials: Batch Records (BRs), Deviation and Corrective and Preventive Action (CAPA) reports, Certificates of Analysis (CoAs), and packaging specifications
• Clinical and safety documentation: Clinical Trial Protocols, Case Report Forms (CRFs), Investigator’s Brochures (IBs), Informed Consent Forms (ICFs), Pharmacovigilance and Safety Reports, and Training materials
Biotech companies
A selection of documents we translate on a daily basis:
• R&D and preclinical materials: research papers, assay documentation, analytical method reports, and validation protocols
• Technology and process documents: Technology Transfer (TT) packages, Product Technical Files (PTFs), and Drug Master Files (DMFs)
• Regulatory and investor communications: safety reports, submission dossiers, and partnership presentations
CMO/CDMO companies
A selection of documents we translate on a daily basis:
• Manufacturing documentation: Master Batch Records (MBRs), Standard Operating Procedures (SOPs), Material Safety Data Sheets (MSDS), Work Instructions, and Validation Protocols and reports
• Quality assurance materials: Analytical Methods, Deviation and Corrective and Preventive Action (CAPA) reports, Certificates of Analysis (CoAs), Good Manufacturing Practice (GMP) guidelines, Good Laboratory Practice (GLP) documentation, Change Control Documentation, and audit findings
• Regulatory and operational records: packaging and labeling specifications, inspection reports, environmental monitoring data
HCPs & Scientific Institutions
A selection of documents we translate on a daily basis:
• Clinical research materials: protocols, Case Report Forms (CRFs), Good Clinical Practice (GCP) documents, and study reports
• Ethical and patient documents: Informed Consent Forms (ICFs), Investigator’s Brochures (IBs), and ethics submissions
• Academic and scientific publications: research papers, conference abstracts, and journal submissions