Pharmaceutical Manufacturing 

Projects in oral solid dose (OSD), biologics, and parenteral manufacturing demand capital strategies that can adapt to scale, compliance requirements, and technology shifts. We support clients across new facility builds, process retrofits, and expansion programs by integrating Program & Project Management, Owner’s Project Manager oversight, and cGMP Compliance & Operational Readiness from start to finish. 

CDMOs and CMO/CDMO Partners 

Contract development and manufacturing organizations face constant pressure to deliver high-quality capacity on compressed timelines. Agile Advisors provides Fractional Leadership to help internal teams scale and mature execution capabilities. We also embed Owner’s Project Managers to manage vendors, align scopes, and defend business outcomes across multiple stakeholders. 

Sterile Fill/Finish and Aseptic Operations 

Aseptic environments require tighter control, earlier risk mitigation, and validation strategies that survive inspection. Agile has supported sterile fill line builds and CQV programs for over $300M in capital. Our CQV Leadership and Project Recovery & Risk Mitigation services are often engaged to support qualification under FDA and EMA scrutiny. 

R&D, Tech Transfer, and Clinical GMP Suites 

R&D facilities, pilot plants, and Phase I/II GMP spaces often operate under tight tolerances with limited resources. Our capital project experience includes clinical manufacturing expansions, QC lab fit-outs, and technology transfer environments requiring compressed project timelines and high audit visibility. We align Program Management and CQV plans to ensure rapid readiness with minimal rework.