We help medical device, diagnostics, and pharma teams go from concept to compliant commercialization—faster—without sacrificing safety or efficacy.
To be the trusted partner that accelerates innovation in medical devices, diagnostic kits, and drug development—empowering life sciences companies to bring safe, effective solutions to patients worldwide.
Practical, audit‑ready solutions led by SMEs in validation, design controls, risk management, and compliance.
Portfolio and program management across diagnostics, therapeutics, and medical devices.
End‑to‑end delivery from milestones and subcontracting to reporting and deliverables.
510(k), PMA, BLA, ANDA, NDA—documentation and readiness for global markets.
SOP tracking, workflow management, and compliance‑ready systems.
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Validation SME & governance for aseptic fill/inspect operations. Implemented Kneat paperless validation; supported Veeva, LIMS/ELN; ensured regulatory readiness.
VMP, FMEA, IQ/OQ/PQ across washing, depyro tunnel, fill, stoppering/capping, RABS, and EM; stage‑wise PV with media fills and CPP/CQA analytics.
Blueprint, equipment selection (HPLC, GC, UV‑Vis, FTIR, dissolution), IQ/OQ/PQ, LIMS configuration, SOPs, and audit‑ready documentation.
Program management, risk, human factors, DV/DV test evidence, and change control to bring DHFs to 21 CFR 820.30 & EU requirements.
System & subsystem requirements, risk management per ISO 14971, comprehensive FMEAs, and HFE deliverables for PFS and on‑body injectors.
A full‑service consulting firm delivering subject‑matter experts across Quality, Compliance, Design Controls, and IT to accelerate safe, effective products to patients.
Share a bit about your program. We’ll align the right SMEs and a practical, compliant path to results.
