Combination Product & Drug Delivery Device Development

Strategic Vision.
Tactical Execution.
One Partner.

Oberhauser Consulting LLC operates as an embedded partner within client development teams, bringing the strategic perspective of an enterprise executive and the hands-on technical depth to do the work, at every stage from concept through regulatory approval.

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25+
Years in pharmaceutical & medical device development
35+
Person device, packaging & sterile process development organization built and led at Gilead Sciences
20+
Pharmaceutical product systems developed and launched across virology, oncology & inflammation

What we do

We work with pharmaceutical, biotechnology, and medical device organizations at every stage of development — from early-stage startups through large enterprises — that need seasoned product development leadership that is embedded, accountable, and deeply technical.

01
Combination Product Development
End-to-end device and combination product design and development execution, including design requirement traceability, design verification and validation, and risk management, for prefilled syringes, autoinjectors, and other drug delivery and combination product systems.
02
Device & Package Development Leadership
Embedded senior leadership for device, packaging, and sterile process development organizations, bringing the functional depth of a large pharmaceutical organization to programs at any stage of development.
03
Supplier & CDMO Development
Coordination and management of the external development ecosystem — device suppliers, test laboratories, and CDMOs — aligning partner capabilities to program requirements and ensuring integrated execution across the full product system.
04
Formulation & Drug Delivery Advisory
Strategic and technical counsel on long-acting injectables, microsphere platforms, container closure systems, combination product target product profiles, and study design for clinical site readiness.
05
Quality System Development
Establishing the documentation architecture, procedural framework, and audit readiness that programs need to withstand FDA and notified body scrutiny — compliant with 21 CFR Part 820 QMSR/Part 4, EU MDR, and ISO 13485/14971.
06
Regulatory Strategy & Submission Support
IND, NDA, BLA, IDE, and PMA development strategy and submission support; FDA interaction and pre-submission meeting preparation; and PAI and inspection readiness for combination product and device programs.
James Oberhauser, Ph.D.
James Oberhauser, Ph.D.
Founder & President

James Oberhauser founded Oberhauser Consulting LLC in 2024 to bring the leadership and technical depth of large pharmaceutical and medical device companies directly to programs that need it most — as a fully embedded partner with the ownership and accountability of a member of a client's team.

His career spans more than 25 years in industry and academic research, including building Gilead Sciences' device, package, and sterile process development function from six packaging engineers to a diversely talented 35+ person organization. He also led development of the world's first biodegradable drug-eluting coronary stent at Abbott Vascular from first-in-human clinical experience through CE Mark and PMA submission.

James holds a Ph.D. in Chemical Engineering from UC Santa Barbara, performed postdoctoral research at Caltech, and served as an Assistant Professor at the University of Virginia. He is a named inventor on more than 30 patents and a published author on more than 25 peer-reviewed journal articles spanning polymer science, drug delivery, and combination product development.

  • Senior Director, Device, Package & Sterile Process Development — Gilead Sciences
  • Senior Manager, Global Product Development (Absorb™ BVS) — Abbott Vascular
  • Assistant Professor, Chemical Engineering — University of Virginia
  • Scientific Advisor — Xeltis B.V.
  • Abbott Laboratories Volwiler Society Innovation Team Award

How we work

Engagements are structured to match your program's stage and needs. Every engagement is led personally by James, ensuring the same senior leadership experience and technical depth from the first conversation through final deliverable.

Embedded
Fully integrated into your team for a defined program phase, operating with the ownership and accountability of a full-time team member.
Fractional
Ongoing part-time senior leadership providing strategic direction and tactical execution across the enterprise.
Project-Based
Defined scope and deliverable for a specific program need, with a clear timeline and outcome from the outset.
Advisory
On-call access for critical decisions, technical reviews, investor diligence support, and strategic inflection points.
Expert Review
A focused, time-limited assessment of a specific program element — a design review, supplier qualification plan, or regulatory strategy — with clear findings and recommendations.
Let's discuss your program.

From early development decisions through regulatory submission, Oberhauser Consulting brings deep device and drug delivery expertise to programs at every stage.