Question 1

Are you ISO 27001 certified for handling pharmaceutical data?

Accepted Answer

Yes, DTP Labs is ISO 27001:2022 certified, which means our information security management system is independently audited and verified to international standards. For pharmaceutical clients, this means your clinical trial documents, patient data, and unpublished research materials are handled under documented controls covering access management, encrypted file transfer, secure storage, audit trails, and staff security training. We also sign comprehensive NDAs with every client before project commencement and can accommodate HIPAA-equivalent workflows for US clients and GDPR compliance for European projects. Our certification is renewed annually through external audits, and we maintain full documentation of our information security policies, incident response procedures, and data retention schedules. This makes us a preferred DTP partner for Fortune 500 pharmaceutical companies and contract research organizations who cannot risk working with vendors lacking formal certification.

Question 2

Which pharmaceutical document types do you specialize in?

Accepted Answer

We handle the complete range of pharmaceutical documents across clinical, regulatory, and commercial functions. Clinical documents include protocols, investigator brochures, informed consent forms, case report forms, site initiation packs, and trial master file components. Regulatory documents cover Module 1-5 submissions, summaries of product characteristics (SmPCs), patient information leaflets (PILs), package inserts, and labeling for EMA, FDA, PMDA, and emerging market submissions. Commercial and training materials include detail aids, MSL slide decks, GMP training courses, field service manuals, and continuing medical education (CME) content. For medical devices, we localize user manuals, quick reference guides, IFUs, and UDI-compliant packaging under EU MDR and FDA 21 CFR 801 requirements. Our team understands pharma terminology, regulatory formatting conventions, and document lifecycle management for documents that undergo frequent amendments and require strict version control.

Question 3

Can you handle EU centralized procedure requirements with 24+ language simultaneous delivery?

Accepted Answer

Yes, parallel multi-language delivery is one of our core strengths. For EU centralized procedure submissions, we set up dedicated project teams per language cluster (Germanic, Romance, Slavic, Finno-Ugric, Greek) working concurrently from a shared translation memory and terminology database. This parallel workflow allows us to deliver 24+ EU official languages in the same timeline as a single-language project, typically 10-15 business days for a standard PIL or SmPC depending on page count and source complexity. We coordinate QRD template compliance, handle both Annex I and Annex IIIA/B components, and deliver print-ready PDFs plus editable source files. Our DTP operators are trained on EMA formatting requirements including mandatory font sizes, bold/italic usage rules, and the specific typographic conventions for each target language to ensure consistent EMA submission quality across all 24 EU markets simultaneously.

Question 4

Do you support Braille and large-print accessibility formats for patient leaflets?

Accepted Answer

Yes, we produce Braille and large-print versions of patient information leaflets as part of our accessibility compliance service. For Braille, we prepare contracted or uncontracted Grade 2 Braille in the target language using certified Braille translation software, then deliver to embossing-ready PRN files or arrange printing through partner Braille printers. For large print, we reformat content to minimum 16-point sans-serif fonts with increased line spacing, adjusted column widths, and accessibility-compliant color contrast per RNIB guidelines. We also produce audio versions of PILs in the form of MP3 files or synchronized DAISY formats when required by national health authorities. All accessibility variants are version-controlled against the master source document to ensure label updates propagate correctly to every accessible format. This meets EU Directive 2004/27/EC Article 56a requirements and equivalent accessibility legislation in other markets.

Question 5

How do you handle protocol amendments and label changes with version control?

Accepted Answer

We maintain strict version control through a combination of translation memory systems, document management workflows, and version comparison tools. When a pharmaceutical client issues a protocol amendment or label change, we first perform an automated change analysis comparing the new source against the previously localized version to identify affected segments. Only changed content is retranslated, while unchanged segments are leveraged from the translation memory at 100% match without re-review, saving time and cost. We track version numbers, amendment codes, and effective dates across all language files, delivering clean change-marked versions and final versions with audit trails. For long-running clinical programs spanning multiple years and dozens of amendments, we maintain dedicated project managers who know your terminology, your preferred linguists, and your document history — ensuring consistency across the entire document lifecycle from first-in-human through post-market pharmacovigilance updates.

Multilingual DTP for Pharmaceutical Companies

What makes Life Sciences & Pharma localization different

Regulatory precision

Multi-language concurrency

Data security

Version control

Our Life Sciences & Pharma capabilities

Clinical trial documents

Regulatory submissions

Patient-facing materials

Medical device documentation

Training and SOPs

Pharmacovigilance materials

1,000-page clinical trial dossier in 12 languages — delivered in 10 days

Services for Life Sciences & Pharma

Translation & Localization

Multilingual Desktop Publishing

File Preparation & Content Engineering

PDF Accessibility & Compliance

Life Sciences & Pharma FAQs

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