Analytical data that has to stand up to an inspection is different from data that only has to be right. We run GMP testing for raw materials, APIs, intermediates and finished products in a laboratory built for that scrutiny.
We provide a full complement of state-of-the-art GMP analytical testing resources and expertise to support the cGMP analyses for raw materials, active pharmaceutical ingredients, intermediates and finished products.
The laboratory operates under GMP certification issued by AIFA, the Italian Medicines Agency, and has been inspected by the FDA. That combination matters for programmes aimed at both European and United States filings, because it means the data package does not have to be re-generated to satisfy a second authority.
We are also authorized to handle high-potency active pharmaceutical ingredients up to OEB5 and controlled substances under Ministry of Health authorization — categories that narrow the field of available laboratories considerably, and that we handle as routine work rather than as exceptions.
Testing is carried out against your specifications, pharmacopoeial monographs, or methods we develop and validate for the purpose.
Identity, purity and conformity testing of starting materials and reagents against specification or monograph.
Full release and characterization testing of APIs, including assay, related substances, residual solvents, elemental impurities and water content.
In-process and intermediate testing, supporting process control and batch disposition decisions.
Testing of finished dosage forms, including dissolution, uniformity and degradation products.
Stability testing under ICH conditions, with the storage, pull schedule and trending that a stability programme requires.
Related substances, degradation products, residual solvents and elemental impurities, quantified against justified limits.
The sequence is the same whether the request is a single release test or a full stability programme, because that is what makes the data traceable.
We agree what is to be tested, against which specification and to which pharmacopoeial or client method, and confirm the method status.
Existing methods are verified or transferred formally in our laboratory; where no suitable method exists, it is developed and validated first.
Samples are received, logged and stored under controlled conditions, with full chain of custody and quantity accountability.
Testing is performed by qualified analysts on qualified instruments, with all raw data recorded and retained under the quality system.
Results undergo second-person review and quality assurance approval. Out-of-specification results are investigated formally.
A detailed technical-scientific report or certificate of analysis is issued, with the raw data package available on request.
The laboratory holds qualified instrumentation across chromatography, spectroscopy, thermal analysis and diffraction, with GMP-qualified systems for release testing.
Every GMP project is delivered with documentation written to be filed, not summarised.
Yes. The laboratory holds GMP certification issued by AIFA, the Italian Medicines Agency, and has been inspected by the FDA.
Either. Client and pharmacopoeial methods are transferred and verified formally in our laboratory. Where no suitable method exists, we develop and validate one following ICH guidelines.
Yes. We are routinely audited by clients and have been inspected by regulatory authorities. Audit documentation and access to raw data are part of the standard arrangement.
Yes. Our facility is authorized to handle high-potency active pharmaceutical ingredients up to OEB5, and controlled substances under Ministry of Health authorization, under GMP certification issued by AIFA and following FDA inspection.
Turnaround depends on the type of analysis, the number of samples and whether methods already exist or have to be developed. We agree the timeline with you when the work is scoped, and tell you early if anything threatens it.
It depends on the techniques involved and on how many determinations are required. We confirm the exact quantity when we scope the work, and design the analytical plan around the material you have.
A detailed technical-scientific report with the methods used, the raw data, the results and their interpretation, issued under our quality system and suitable for inclusion in regulatory documentation.
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 specification and the material. We will confirm method status, scope, timeline and cost before starting.