
Navigate development and submission milestones with ExonCode Consulting LLC. Services include U.S. IND application support; pre-IND and other FDA meeting preparation; Drug Master File (DMF) submissions; NDA/ANDA submission support; Orphan Drug Designation and Fast Track designation requests; and domestic agent services for overseas marketing authorization holders (MAHs) in China. Engagements are tailored to the product, development stage, and applicable FDA or NMPA pathway.

Data-first. Algorithm-guided. Biologically grounded. We tailor NGS analysis to single-cell, spatial, bulk RNA-seq, WGS, metagenomic, and metatranscriptomic datasets. Choose the strategy your question needs: established statistical pipelines for robust comparisons; reference-guided annotation and integration; unsupervised discovery of cell states and tissue patterns; or machine learning and deep learning approaches evaluated for the dataset. Quality control, appropriate validation, interpretable outputs, and expert review connect computational results to biological context.

Bring AI-driven analysis into your research with BiDesk. Access ExonCode's dedicated platform to explore data and support scientific analysis, alongside our custom bioinformatics services. Pair AI-assisted exploration with expert interpretation to move from complex datasets toward meaningful biological questions. Explore BiDesk at app.exoncodes.com.

A dedicated platform for clinical genetic testing analysis and professional review. Connect clinical genomics data with analysis workflows that support laboratory interpretation. Clinical implementation follows laboratory-validated procedures, qualified professional oversight, and applicable CLIA and California requirements. Contact bioinfo@exoncode.com to request platform access or discuss your laboratory's workflow.
Discuss your research goals, analysis needs, or regulatory strategy with the ExonCode team.
By appointment. Contact us to discuss your project.

Resolve cellular heterogeneity with quality control, doublet assessment, normalization, dimensionality reduction, clustering, and cell-type annotation. Compare conditions with differential expression and pathway analysis; extend to trajectory analysis or cell-cell communication when appropriate to the study. Deliverables are tailored to your experimental design.

Place gene expression in tissue context. Analyze spatial quality metrics, expression patterns, tissue domains, spatially variable genes, and regional pathway activity. Integrate single-cell references for cell-type mapping or deconvolution where supported by the assay. Connect molecular signatures with tissue architecture through interpretable visualizations.

From raw reads to biological interpretation: sequencing QC, alignment or transcript quantification, sample-level assessment, differential expression, and pathway enrichment. Study-aware statistical models account for relevant covariates and batch effects. Clear visualizations and documented methods support reproducible research and scientific communication.

Characterize genomic variation with read QC, alignment, coverage assessment, variant calling, filtering, and annotation. Small-variant, copy-number, and structural-variant analyses are scoped to the data and research objective. Cohort comparisons and prioritized findings help focus downstream investigation, with transparent methods and documented quality metrics.

Investigate microbial community composition, functional potential, and transcriptional activity. Workflows can include host-read removal, taxonomic profiling, diversity analysis, functional annotation, and between-group comparisons. Integrate metagenomic DNA and metatranscriptomic RNA to connect which organisms are present with the functions they express, according to study design and data quality.

Start with the scientific question, then select the right computational strategy. Combine curated public and project data, reproducible algorithms, and fit-for-purpose statistical or learning-based models. Explore deep learning for representation learning, cell-state discovery, and multi-omics integration where appropriate. Model evaluation considers held-out data, batch effects, confounding, and interpretability; expert review connects predictions to biology. Deliverables can include documented workflows, quality metrics, visualizations, and a tailored analysis report.
ExonCode Consulting LLC
Rancho Cordova, CA 95670
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