Insights

Case Studies & Regulatory Perspective

How compliance science moves projects from validation to industrialization — and the policy shifts shaping the path.

Approach

How we structure the work

Approach · GLP

Taking the handoffs out of nonclinical evaluation

Why organ-chip prescreening sits ahead of the GLP phase — and what it does not change.

Approach · Organoid Validation

When traditional animal models can't capture how a new biomaterial really behaves

Organ-chip prediction as a complement to the ISO 10993 battery, not a substitute for it.

Policy Watch

Regulatory & Industry Perspective

Readiness Tool · Effective 2026-11-01

2026 GMP Readiness Check

Five questions to put to your contract manufacturer before the effective date, and our own answers.

Policy Watch · New

China's revised medical device GMP takes effect 1 November 2026: what changes for contract manufacturing

15 chapters instead of 10, and a dedicated chapter on contract manufacturing and external processing — plus the five questions to settle with your manufacturer before the effective date.

China's 2026 regulatory reform: what it means for GLP and CDMO timelines

Faster clinical trial review and new rare-disease device pathways, explained.

Surgical robotics & high-end device localization: where CDMO capacity becomes the bottleneck

Why process-transfer capacity — not R&D — is the real constraint as precision requirements climb.

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