cGMP
Drug & Biologic GMP
21 CFR 210/211 and the ICH quality guidelines — the current Good Manufacturing Practice regime behind every small molecule and therapeutic biologic, from clinical supply to commercial launch.
Industries
Six regulated industries. One standard of leadership.
Wherever your product sits in the life sciences, the consultant who leads your engagement has held the seat inside that industry — and knows the framework, the inspectorate, and the failure modes that come with it.
- 6Regulated industries
- US + EUFrameworks we run
- End-to-endConcept to post-market
Operators, not tourists
Every industry runs by its own rulebook. We’ve worked from inside each.
A drug company lives under GMP; a device company runs a quality system; an advanced-therapy developer answers to a biologics center where the science outpaces the guidance. The standards, the inspection cadence, and the way a submission is read all change with the industry — even when the underlying law looks the same.
Our consultants have held the seat you’re hiring for — in your industry, under the framework that governs it. So the plan we bring already fits how your sector actually operates, not a generic template.
The Directory
Find your industry
Six sectors of deep expertise. Each links to how we lead engagements in its regulatory environment, from first strategy to post-market.
-
Pharmaceuticals Small molecules and biologics, molecule to market.Explore -
Biotechnology Emerging platforms with first-time regulatory questions.Explore -
Medical Devices Design history to post-market surveillance, every class.Explore -
In Vitro Diagnostics Assays, analyzers, and the evidence behind every result.Explore -
Regenerative Medicine Living therapies where the process is the product.Explore -
Healthcare Technology Software and AI, cleared like the devices they are.Explore
Know your framework
Every product answers to a governing regime.
Your industry decides which rulebook you build to — and each is enforced by a different inspectorate that reads evidence its own way. We staff consultants who have run programs under the one that governs yours.
cGMP
QMSR
Device Quality System
FDA’s Quality Management System Regulation — now harmonized to ISO 13485 — plus ISO 14971 risk management, governing devices and the assays and analyzers of diagnostics.
CBER
Advanced Therapies
Reviewed at the biologics center under 21 CFR 1271, where potency, comparability, and manufacturing control carry the file — and precedent is thin because the science moves fastest.
SaMD
Software as a Medical Device
IEC 62304 software lifecycle, the FDA Software-as-a-Medical-Device framework, and premarket cybersecurity — the regime for products where the code itself treats and diagnoses.
Straddling drug and device? A combination product or companion diagnostic pulls two regimes into one submission — and the seam between them is where programs stall. We staff for the cross-framework path, not just the lead center.
Straddling two of them? Most interesting programs do.
Tell us the product, the market, and the milestone in front of you. We’ll match you to consultants who have led in that industry, under that framework.