Regulatory Dossier & CTD Translation for Global Pharma

High-precision B2B translation and linguistic validation of complete Regulatory Dossiers (CTD structure) for health ministries, EMA, FDA, and cross-border regulatory approvals. Strict subject-matter alignment managed under rigorous NDA.

Initiate Dossier Analysis

ISO 17100

ISO 9001:2015

CTD Compliance

39+ Languages

TM Cost Optimization

Compliant Technical Translation of All CTD Modules

Modules 1 & 2

Linguistic processing of administrative data, Summaries of Product Characteristics (SmPC), patient leaflets, quality summaries, and clinical overviews.

Module 3 (Quality)

Precise B2B translation of chemical, pharmaceutical, and biological validation records, drug substance manufacturing data, and GMP certification assets.

Modules 4 & 5

Elite validation of non-clinical toxicological studies, clinical trial reports (CSRs), investigator brochures, and pharmacovigilance tracking databases.

Word-Based Enterprise Pricing (Stepes Aligned)

Administrative, Chemical & GMP Dossier Nodes

from $0.15 USD / word

Includes full cloud translation memory database synchronization and technical asset logging

Clinical Protocols & Pharmacovigilance Submissions

Custom B2B Estimation

Multi-stage linguistic QA pipelines with final verification executed by practicing MDs

Pharmaceutical Document Integrity FAQ

How do you handle strict data privacy and regulatory compliance updates?

All target assets are processed within localized cloud CAT infrastructures. Master Non-Disclosure Agreements (NDA) are mandatory for all parties. Furthermore, our translation memory architectures guarantee that any subsequent amendments or regulatory text updates are processed with highly optimized turnaround times.