Digital health and diagnostics visualization

Industries

The Full Spectrum of Life Sciences.

We bring deep, specialized expertise across every major life sciences vertical — understanding the unique regulatory, clinical, and commercial dynamics of each.

Pharmaceuticals

Small molecule drug development from hit-to-lead through lifecycle management, including generics and specialty pharma strategy.

NCE development strategy505(b)(2) pathway optimizationLifecycle managementGeneric entry strategy

Biotechnology

Biologics, monoclonal antibodies, and biosimilar programs with deep understanding of CMC complexity and regulatory nuance.

Biologics developmentBiosimilar strategyManufacturing scale-upPatent dance navigation

Medical Devices

Class I through Class III devices across cardiovascular, orthopedic, neurological, and surgical specialties.

510(k) & PMA strategyDesign controls advisoryClinical evidence generationEU MDR transition

Cell Therapy

Autologous and allogeneic cell therapy programs including CAR-T, TCR, TIL, and stem cell-derived therapies.

Manufacturing strategyRMAT designationSupply chain designReimbursement planning

Gene Therapy

AAV, lentiviral, and next-generation gene therapy platforms with expertise in rare disease and orphan drug strategy.

Vector development strategyDurability evidence planningOrphan drug designationGene editing platforms

Diagnostics

In vitro diagnostics, companion diagnostics, and laboratory developed tests across molecular, immunoassay, and imaging modalities.

CDx co-developmentIVD regulatory strategyCLIA/LDT compliancePrecision medicine platforms

Digital Health

Software as a Medical Device (SaMD), digital therapeutics, AI/ML-enabled diagnostics, and remote patient monitoring.

SaMD classificationPredetermined change controlAI/ML regulatory strategyReal-world evidence

Combination Products

Drug-device, biologic-device, and drug-device-biologic combinations requiring coordinated regulatory and development strategies.

Primary mode of actionCombination product strategyCross-center coordinationIntegrated testing

Don't See Your Exact Vertical?

Our expertise extends across the full life sciences landscape. If your area isn't listed, we likely have relevant experience. Let's talk.