Since 2005Solid-state science
Medicina (BO) — Italy
Solid-State CRO / CDMO — Capability Statement

Four regulated capabilities.
One European site.

GMP-certified analytical quality system, controlled-substances authorisation, HPAPI containment to OEB5 and full structure determination — a combination we have not found in any other European solid-state CRO across our 2026 competitor benchmark.

GMP analytics — AIFA certified
FDA-inspected facility
Controlled substances — MoH authorised
HPAPI up to OEB5
SC-XRD · Neutron · MicroED
The capability stack

GMP analytics

AIFA-certified GMP analytical department on an FDA-inspected facility. One quality system, one set of procedures, serving both EU and US filings.

Controlled substances

Ministry-of-Health authorisation for controlled substances, with segregated storage, chain-of-custody and reconciliation. Narcotics and psychotropics handled in-house, with no third-party transfer.

HPAPI to OEB5

Containment validated for OEB5 (<1 µg/m³): cytotoxics, ADC payloads and high-potency APIs screened, characterised and processed in-house, without outsourcing the potent steps.

Structure determination

Single Crystal XRD (lab or synchrotron), neutron diffraction and MicroED: 3D structures and absolute configuration, including sub-micron crystals where SC-XRD fails.

Representative engagements — indicative scope

Form selection to a developable solid

Profile 01
Typical brief
Small molecule, BCS II/IV, heading for IND/IMPD: no developable form identified, or an amorphous phase that recrystallises on stability.
Our scope
Extended polymorph screening across solvent, cooling, anti-solvent and slurry routes; salt and co-crystal screening where the free form is not viable; interconversion and slurry bridging to rank stability.
You receive
Full XRPD / DSC / TGA / DVS dataset, an enantiotropic–monotropic hierarchy, and a CMC-ready form-selection report.
8–12weeks, typical
1site, no re-transfer
CMCreport for filing

Potent and controlled molecules

Profile 02
Typical brief
An OEB4–OEB5 API, a scheduled substance, or both — where suppliers can offer containment or a licence, but rarely the two together.
Our scope
Handling inside validated containment under Ministry-of-Health authorisation: form and salt work, crystallisation development, micronisation and non-GMP kilo-lab supply, with full chain-of-custody.
You receive
Isolated batch with full analytical documentation, process description and tech-transfer package.
OEB5<1 µg/m³ containment
MoHauthorised custody
GMPanalytical release

What we do

Analyze

XRPD, DSC/TGA, DVS, HPLC/UPLC, particle sizing, structure determination & absolute configuration, GMP release & stability.

R&D

Polymorph, salt and co-crystal screening, form selection, crystallisation process design, amorphous solid dispersions.

CDMO

Process scale-up, non-GMP kilo-lab supply (50 L), micronisation, spray drying and tech transfer.

Why it matters to your programme

One site means no re-transfer between a screening lab, a potent-handling site and a licensed facility — the single largest source of lost weeks in solid-state development. Same team, same quality system, from first screen to kilogram supply.

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