Day Translations
Genomics & Precision Medicine

Genomics & Precision MedicineTranslation Services

Expert translation for genomics companies, precision medicine programs, and gene therapy developers — covering NGS protocols, CRISPR regulatory filings, companion diagnostic documentation, and biomarker study materials in 500+ languages.

ISO 17100 CertifiedNGS · Gene TherapyCompanion Dx

ISO 27001 information security · HIPAA-aligned · GSA-approved vendor

GDPR · AICPA SOC 2 Ready · HIPAA Compliant · ISO 17100 Certified · ISO 27001 Certified · ATA Member · BBB A+ Rating
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Genomics Documents
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Our Services

Specialized translation for genomics & precision medicine.

Specialized translation for every document type in the genomics and precision medicine sector.

NGS / WGS

NGS & Whole Genome Sequencing Protocols

Translation of next-generation sequencing protocols, bioinformatics pipelines, and whole genome sequencing study materials for clinical and research applications.

Gene Therapy

Gene Therapy Regulatory Filings

IND, CTA, and BLA filings for gene therapy and cell therapy products, including AAV vector documentation, manufacturing process descriptions, and preclinical safety data.

CRISPR

CRISPR & Gene Editing Documentation

Scientific publications, patent applications, regulatory submissions, and clinical protocols for CRISPR-Cas9, base editing, and prime editing programs.

Companion Dx

Companion Diagnostic Documentation

510(k) and PMA submissions for companion diagnostics, including analytical validation reports, clinical performance studies, and labeling for co-developed CDx products.

Biomarker

Biomarker Study Materials

Biomarker qualification plans, biomarker-driven trial protocols, liquid biopsy study materials, and pharmacogenomics documentation for precision oncology programs.

Precision Onco

Precision Oncology Trial Documents

Protocol translations for basket trials, umbrella trials, and platform trials in precision oncology, including molecular tumor board materials and genomic profiling reports.

Regulatory

Genomics Regulatory Submissions

FDA Breakthrough Therapy, EMA PRIME, and PMDA Sakigake designation applications for genomic medicines, including scientific advice request translations.

Patient

Patient Genomic Reports

Clinical genomic test reports, patient-facing variant interpretation summaries, and genetic counseling materials translated for diverse patient populations.

Regulatory Compliance

Built for global regulatory requirements.

Every translation is designed to meet the specific requirements of the target regulatory authority.

FDA 21 CFR Part 58
GLP Standards

Good Laboratory Practice regulations governing non-clinical laboratory studies supporting genomics-based IND and BLA submissions to FDA.

FDA Gene Therapy Guidance
Gene Therapy Oversight

FDA guidance documents for human gene therapy products, including manufacturing, preclinical, and clinical considerations for IND submissions.

EMA CAT Guidelines
Advanced Therapy Medicinal Products

European Medicines Agency Committee for Advanced Therapies guidelines for gene therapy, somatic cell therapy, and tissue-engineered products.

ICH E15
Pharmacogenomics

ICH E15 guideline on definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data, and sample coding categories.

ISO 15189
Medical Laboratory Accreditation

International standard for quality and competence in medical laboratories, applicable to clinical genomics testing facilities and NGS diagnostic labs.

GDPR / HIPAA
Genomic Data Privacy

Strict compliance with genomic data privacy regulations — GDPR Article 9 (special categories) and HIPAA for protected health information in genomic research.

Why Day Translations

The genomics & precision medicine partner trusted globally.

The genomics and precision medicine revolution is transforming drug development, diagnostics, and patient care at an unprecedented pace. As genomic technologies — from next-generation sequencing to CRISPR gene editing and CAR-T cell therapies — move from research into clinical practice, the demand for highly specialized translation has grown exponentially. Day Translations has built a dedicated genomics practice staffed by linguists with advanced degrees in molecular biology, genetics, bioinformatics, and regulatory affairs.

Our team understands the unique challenges of this field: the rapidly evolving scientific terminology, the complex regulatory landscape for advanced therapy medicinal products (ATMPs), and the critical importance of precision in translating variant classifications, genomic coordinates, and statistical analyses. We maintain specialized genomics glossaries in all major languages, updated continuously to reflect the latest HGNC gene nomenclature, ACMG variant classification standards, and ISCN cytogenetic notation.

For gene and cell therapy programs, we provide regulatory specialists who understand the requirements of FDA's Office of Tissues and Advanced Therapies (OTAT), EMA's Committee for Advanced Therapies (CAT), and PMDA's Center for Product Evaluation — supporting IND, CTA, and BLA filings for AAV-based gene therapies, CAR-T cell therapies, and mRNA therapeutics with translations that meet each authority's formatting and content requirements.

Genomics & precision medicine translation

Key Capabilities

  • HGNC gene nomenclature & ACMG variant classification
  • AAV, lentiviral, and mRNA therapy documentation
  • CAR-T and TCR-T cell therapy regulatory filings
  • NGS bioinformatics pipeline documentation
  • CRISPR patent applications & IP documentation
  • Companion diagnostic 510(k)/PMA submissions
  • Genomic data privacy (GDPR/HIPAA) compliance
  • Liquid biopsy & ctDNA study materials
Who We Serve

Serving the full genomics & precision medicine ecosystem.

Gene Therapy Developers

Companies developing AAV-based gene therapies, lentiviral vectors, mRNA therapeutics, and cell therapies requiring regulatory translation for FDA, EMA, and PMDA submissions.

  • IND/CTA/BLA for gene therapy products
  • AAV manufacturing process documentation
  • Preclinical safety & toxicology reports
  • ATMP regulatory submissions (EMA CAT)
  • Patient informed consent for gene therapy

Precision Oncology Programs

Pharmaceutical companies and academic centers developing biomarker-driven oncology therapies requiring companion diagnostic co-development and genomic trial translations.

  • Basket & umbrella trial protocols
  • Companion diagnostic 510(k)/PMA filings
  • Biomarker qualification plans
  • Molecular tumor board materials
  • Genomic profiling report translation

Genomics Diagnostics Companies

Clinical genomics testing laboratories and NGS diagnostic companies requiring translation of test reports, clinical validation studies, and regulatory submissions.

  • Clinical genomic test reports
  • NGS validation study documentation
  • ISO 15189 accreditation materials
  • Patient-facing variant interpretation
  • Genetic counseling materials
Our Process

Six-step genomics translation process.

01

Scientific Assessment

Genomics specialist reviews document type, technology platform, and regulatory target to assign linguists with matching scientific expertise.

02

Genomics Glossary Alignment

Client-specific genomics terminology database loaded, including gene names, variant classifications, and assay-specific terms.

03

Expert Translation

Molecular biologist or geneticist with regulatory translation experience produces the translation with full scientific accuracy.

04

Scientific Review

Second qualified genomics linguist independently reviews for scientific accuracy, terminology consistency, and regulatory compliance.

05

QA & Validation

Quality assurance review with back-translation for critical patient-facing documents. Formatting verified against source.

06

Certified Delivery

Final document delivered with Certificate of Translation, updated TM, and full audit trail for regulatory submission.

FAQ

Frequently asked questions.

All genomics translators on our team hold advanced degrees (MSc or PhD) in molecular biology, genetics, bioinformatics, biochemistry, or a related discipline. Many have direct research experience in genomics laboratories or regulatory affairs roles at genomics companies. We do not use general medical translators for genomics documents — the scientific complexity requires specialist expertise.

Yes. We have extensive experience translating IND, CTA, and BLA filings for gene therapy products for both FDA (OTAT) and EMA (CAT). Our regulatory specialists understand the specific content requirements for AAV-based gene therapies, lentiviral vector products, and mRNA therapeutics, including manufacturing process descriptions, preclinical safety data, and clinical protocols.

We maintain continuously updated genomics terminology databases in all major languages, aligned with HGNC gene nomenclature, ACMG/AMP variant classification standards, and ISCN cytogenetic notation. Our terminology managers monitor publications from NCBI, EMBL-EBI, and major genomics journals to ensure our glossaries reflect current scientific usage.

Yes. We provide integrated translation services for co-developed drug and companion diagnostic programs, ensuring that biomarker definitions, assay descriptions, and clinical performance data are translated consistently across both the drug NDA/BLA and the companion diagnostic 510(k)/PMA. This is critical for FDA submissions where the drug and CDx are reviewed together.

Yes. We translate clinical genomic test reports, patient-facing variant interpretation summaries, and genetic counseling materials. These documents require both scientific accuracy and plain-language accessibility. Our translators are trained in health literacy principles and follow ACMG guidelines for variant classification and reporting.

We cover 500+ languages for genomics translations, with particular depth in the major regulatory markets: English, Japanese, Chinese (Simplified and Traditional), German, French, Spanish, Italian, Portuguese, Korean, and Russian. For rare languages, we can typically mobilize qualified genomics translators within 48–72 hours.

All genomics projects are handled under strict mutual NDAs and confidentiality agreements. We use encrypted file transfer, role-based access controls, and secure project management platforms. Our information security practices are aligned with ISO 27001. We do not use AI translation tools for proprietary genomics data without explicit client consent.

Yes. We translate CRISPR and gene editing patent applications in all major patent jurisdictions, including USPTO, EPO, WIPO (PCT), and JPO. Our patent translators combine genomics scientific expertise with patent law knowledge to ensure that claims, specifications, and sequence listings are translated with the precision required for IP protection.

Ready to advance your genomics program?

Contact our genomics & precision medicine translation specialists. We respond within 15 minutes during business hours.

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Genomics & Precision Medicine Translation | NGS, Gene Therapy & Companion Dx | Day Translations