Launching a regulated healthcare, GMP, or compounding business requires more than a facility and a license. We work alongside founders to design the operational, regulatory, and quality infrastructure needed to launch with confidence from facility design and licensing strategy to SOP architecture, staffing models, and inspection readiness.
Strategy • Facility design • SOP suite • Licensing • Training • Validation evidence
Comprehensive consulting for compounding & personalized medicine start-ups
To BUILD a successful 503A, 503B, telehealth platform, med spa, cell & gene lab, analytical testing lab, or API wholesale facility.
Personalized medicine start-ups -
Entrepreneurs starting a large mail order multi-state licensed 503A sterile and nonsterile compounding pharmacy
Pharmacies expanding into 503B outsourcing
Telehealth platforms building an integrated pharmacy or dispensing model
Investors building a vertically integrated healthcare ecosystem that includes a 503A pharmacy, 503B outsourcing facility, telehealth platform, analytical testing lab, API sourcing arm, and a med spa or clinic chain
Academic- or health system-affiliated 351 cell & gene therapy lab or 361 stem cell therapy lab start-ups
The services below bring new personalized medicine firms to market in three-phases (a la carte services also available).
