PCL Research & Manufacturing is a contract research and manufacturing organization, leader in solid-state chemistry and API crystallization. GMP-certified analytical laboratory · FDA inspected · HPAPI OEB5 · serving pharmaceutical clients worldwide for over 20 years.
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.
Scientific publications, industry news and company announcements from PCL Research & Manufacturing.
PCL 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 CPHIWe'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 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 R&M 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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