PCL Research & Manufacturing is an integrated CRO/CDMO: solid-state R&D, GMP analysis and non-GMP manufacturing under one roof. Its laboratory, certified by AIFA and inspected by the FDA, handles high-potency APIs up to OEB5 and controlled substances — one of the few in Europe to combine all three.
PCL Research & Manufacturing is one of the few laboratories in Europe that hold all three, so a potent, scheduled API can be analysed end to end without splitting the work across sites.
Certified by AIFA, the Italian Medicines Agency, and inspected by the U.S. FDA.
Certificate IT/90/H/2025 GMP Analysis OEB5Analysis and handling of HPAPIs up to OEB5, with containment and procedures built for the tightest exposure limits.
Up to OEB5 HPAPI analysis MoHAuthorized by the Italian Ministry of Health to receive, store and analyse narcotic and psychotropic APIs.
Ministry of Health authorization Controlled substancesWhere they meet: a potent, controlled API analysed under GMP, with one quality system, one register and one chain of custody.
PCL Research & Manufacturing s.r.l. is a privately owned CRO/CDMO providing reliable solutions to optimise and control the crystallisation process of Active Pharmaceutical Ingredients — since 2005.
Our mission is to support clients during drug development, helping them reduce batch failure, avoid costly crystallisation issues and offer greater confidence in drug quality. We support you from early-phase discovery to kilogram-scale non-GMP supply.
We are a high-performing team of trained chemists and analysts with more than 20 years of experience in API crystallization, caring about results and innovation based on sound science.
Discover the CompanyFrom analytical characterization to kilogram-scale non-GMP manufacturing — complete pharmaceutical development support.
Complete range of GMP-certified analytical capabilities. FDA inspected, authorized for HPAPI handling up to OEB5.
From co-crystal discovery to process optimization — unique solid-state experience. Data-driven, de-risk your API development.
Contract development & non-GMP manufacturing from development batches to kilogram-scale supply. Robust scale-up transfer.
We are authorized by the Italian Ministry of Health to study, produce and analyze controlled substances and highly potent APIs up to OEB5 — with dedicated containment and handling protocols that keep your most demanding molecules safe at every step.
Our analytical facility operates under strict regulatory compliance, giving pharmaceutical partners worldwide complete confidence in quality and integrity.
Our analytical facility has been inspected by the U.S. Food & Drug Administration, confirming adherence to international pharmaceutical quality standards.
Our analytical department is certified to work according to GMP by AIFA. Certified: XRPD, FT-Raman, FT-IR and Particle Size Distribution.
Authorized by the Italian Ministry of Health for the study, production and analysis of controlled substances and HPAPIs up to OEB5.
A single A4 sheet covering our GMP-certified analytics, controlled-substances authorisation, HPAPI containment to OEB5 and full structure determination — plus two representative engagement profiles with typical scope and timelines. Written for the people who need to compare suppliers quickly.
Print-ready A4 · English · no form required
The full picture: why the solid form decides whether a drug works, what each of our four capabilities covers, four anonymised engagements showing the work in practice, and how a programme runs from first conversation to final report.
12 pages · print-ready A4 · English · no form required
Scientific publications, industry news and company announcements from PCL Research & Manufacturing.
A closer look at why rushing CMC data packages often costs more time than it saves — and what to do instead.
A practical, stage-by-stage checklist for validating XRPD, DSC/TGA, SS-NMR and Raman methods without over-investing early or scrambling late.
An anonymized case study on reconciling high-containment safety, analytical sensitivity, and audit-ready data for a cytotoxic intermediate.
Polymorph screening tells you what a molecule did in the lab. CrystallQ, the AI-supported platform PCL Research & Manufacturing is now developing, is built to tell you what it is likely to do — ranking probable crystal forms, packing motifs and salt or co-crystal candidates from structure alone, before a single vial is set up. The aim is not to replace the experiment but to aim it: fewer blind screening routes, earlier warning of a metastable form, and a shorter path to a developable solid. Built on two decades of PCL Research & Manufacturing crystallization data and validated against our own experimental results.
We are looking for pilot partners. If you have a molecule that has resisted conventional screening, we would like to test CrystallQ against it — and share what we find with you.
Developed in line with Regulation (EU) 2024/1689 (the AI Act): predictions are scientific decision support, always reviewed by our scientists, never trained on your data for anyone else. How we govern AI.
Join the CrystallQ pilotAn API that is stable on its own can still fail in the tablet. Our new program tests your solid form against the excipients, the process and the moisture of the product, looking for chemical degradation and solid-state changes such as salt disproportionation or polymorphic conversion, before the formulation is locked.
Discover the programA practical guide to choosing the solid form of an API: polymorphs, hydrates, the amorphous state, salts and co-crystals — what each one changes, when each is available, and what it costs to decide late. Includes a side-by-side comparison of the five approaches.
Read the white paperNine fairs, conferences and partnering meetings on both sides of the Atlantic: CPHI Milan, AAPS PharmSci 360, DCAT Week, BIO-Europe Spring, the BCA Spring Meeting, the Global DDF Summit, BOS Basel, Farmaforum and CPHI Frankfurt. The full calendar, with dates, venues and a meeting request for each event, is on the new Events page.
See the events calendarPCL Research & Manufacturing will take part in CPHI Milan 2026 — the world's largest pharma event — held at Fiera Milano, 6–8 October 2026. Let's discuss your API crystallization, HPAPI and solid-state projects in person. Book a meeting with our team.
Request a meeting at CPHIPCL Research & Manufacturing will be at AAPS PharmSci 360 in New Orleans, 25–28 October 2026 — the reference meeting for pharmaceutical sciences in North America. A good place to talk polymorph and co-crystal screening, amorphous dispersions and structure determination with the scientists who run the work.
Request a meeting at AAPSWe'll also attend DCAT Week 2027 — the premier business-development event for the global pharmaceutical manufacturing value chain — in New York City, 15–18 March 2027. Schedule a one-to-one meeting to explore how PCL Research & Manufacturing can support your development pipeline.
Request a meeting at DCATPCL Research & Manufacturing extends its analytical portfolio with full structure determination and absolute configuration assignment. The offer combines Single Crystal XRD (lab instrument or synchrotron based), Neutron Diffraction for precise hydrogen positions and hydrogen-bond networks, and Micro Electron Diffraction for structures from sub-micron crystals that cannot be grown any larger. Together they resolve chirality, confirm salt versus co-crystal nature and support patent and regulatory filings.
Explore the serviceUnderstanding solid-state properties early helps avoid manufacturing problems and improve drug performance and bioavailability.
PCL Research & Manufacturing expands controlled substance analytical services with full OEB5 authorization from the Italian Ministry of Health.
How robust process development de-risks the transition from lab-scale to non-GMP API manufacturing.
Analytical testing, solid form screening, or non-GMP development & manufacturing — our team of experts is ready to support your drug development program.
Via F.S. Fabri, 127/1 — 40059 Medicina (BO), Italy
Via Della Cooperazione, 29 — 40059 Medicina (BO), Italy
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