Narcotic and psychotropic APIs carry a second layer of regulation on top of GMP. We hold the Italian Ministry of Health authorization to receive, store, analyse and dispose of controlled substances, inside the same AIFA-certified GMP laboratory.
In Italy, handling narcotic and psychotropic substances requires a specific authorization from the Ministry of Health under D.P.R. 309/1990, separate from GMP certification. Moving the material across borders also requires import and export authorizations under the international drug control conventions.
Most analytical laboratories hold one framework or the other. Few hold both, and fewer still combine them with containment for high-potency material. For a scheduled API, that usually means splitting the analytical work across sites, with an authorization to obtain for each movement.
Holding all three in one laboratory means a controlled — and, if needed, potent — API can be characterized, released and studied in one place, under one quality system and one register.
The analytical services available on any API are available on controlled ones, within the scope of our authorization.
Release testing and stability studies under ICH conditions on controlled APIs, intermediates and finished products.
Analytical methods developed and validated following ICH guidelines, designed to keep material consumption low.
Crystal form screening, characterization and form selection on scheduled molecules.
Crystal structure and absolute configuration, which for chiral controlled substances can be a regulatory question in itself.
Dissolution and solubility studies for form selection and formulation development.
Identification and quantification of process impurities and degradation products.
The timeline of a controlled-substance project is set mostly by the authorizations, so we plan them first.
We confirm how the substance is classified in Italy and in the country of origin, and that it falls within the scope of our authorization.
For shipments from outside Italy we prepare the Italian import side and coordinate with you on the export authorization, so the timeline is known before work starts.
Material is received, registered and stored under the conditions the authorization requires.
Every quantity used is recorded, so the register reconciles at the end of the project.
Results undergo second-person review and quality assurance approval before the report is issued.
Residual material is returned or destroyed according to the applicable procedure, with documentation.
These are the documents your supplier qualification will ask for. We send copies with the quotation.
Every project ends with a detailed technical-scientific report, issued under our quality system.
Narcotic and psychotropic substances within the scope of our Ministry of Health authorization. Send us the classification of your compound and we confirm before quoting.
Yes, with import and export authorizations. Their timing depends on the authorities of both countries, which is why we plan them at the start of the project.
We prepare the Italian side and coordinate with you on the export authorization in the country of origin.
Yes. The same laboratory handles HPAPIs up to OEB5, so potent and controlled work does not have to be split between sites.
It depends on the techniques involved. Because every milligram is registered, we plan the work to use as little as possible and confirm the quantity when the project is scoped.
Yes. Client audits are routine. The laboratory holds AIFA GMP certificate IT/90/H/2025 and has been inspected by the FDA.
Work starts only after a confidentiality agreement is in place. Samples, data and reports remain yours and are never shared or reused.
Send us the compound's classification, the country it ships from and what you need to know. We will come back with the authorization plan, the material requirement and a timeline.