# PCL Research & Manufacturing s.r.l.

> GMP analytical laboratory certified by AIFA (certificate IT/90/H/2025) and inspected by the U.S. FDA, specialised in high-potency APIs up to OEB5 and controlled substances (Italian Ministry of Health authorization) — one of the few laboratories in Europe holding all three. Also an independent CRO/CDMO in pharmaceutical solid-state chemistry and API crystallization, based in Medicina (Bologna), Italy, since 2005.

Key facts:
- Services: polymorph, salt and co-crystal screening; solid form selection; amorphous dispersions; preformulation; crystallization process development and scale-up; GMP analytical testing; ICH method validation; crystal structure and absolute configuration determination (single crystal XRD, synchrotron, neutron diffraction, MicroED); non-GMP kilo-lab manufacturing.
- Deliverable: a detailed technical-scientific report; for manufacturing projects, also the synthesized material.
- Timelines and sample quantities depend on the specific study and are agreed at scoping.
- Contact: businessdev@pcl-rm.com · +39 353 4388305 · Via F.S. Fabri 127/1, 40059 Medicina (BO), Italy.

## Core: potent and controlled APIs under GMP
- [HPAPI Analytical Testing up to OEB5](https://www.pcl-rm.com/hpapi-oeb5/): GMP analytical testing and solid-state work on high-potency APIs up to OEB5. AIFA-certified laboratory (IT/90/H/2025), FDA inspected. Medicina, Italy.
- [Controlled Substances Analytical Laboratory](https://www.pcl-rm.com/controlled-substances/): GMP analytical testing on narcotic and psychotropic APIs, authorized by the Italian Ministry of Health. AIFA GMP certificate IT/90/H/2025, FDA inspected.

## Company
- [Home](https://www.pcl-rm.com/): AIFA GMP analytical laboratory, FDA inspected, for high-potency APIs up to OEB5 and controlled substances. Solid-state chemistry CRO/CDMO in Italy.
- [Company](https://www.pcl-rm.com/company/): Privately owned CRO/CDMO with 20+ years in API crystallization and solid-state chemistry. GMP-certified lab (AIFA), FDA inspected, HPAPI OEB5. Medicina, Italy.
- [Case Studies](https://www.pcl-rm.com/case-studies/): Anonymised case studies in API solid-state chemistry: a late polymorph discovery resolved before filing, and a co-crystal route for a non-ionisable molecule.
- [Events & Trade Fairs 2026–2027](https://www.pcl-rm.com/events/): Where to meet PCL Research & Manufacturing in 2026–2027: CPHI Milan, AAPS, DCAT, BIO-Europe Spring, BCA, DDF Summit, BOS Basel, Farmaforum and CPHI Frankfurt. Book a meeting.

## R&D services
- [R&D](https://www.pcl-rm.com/rd/): Polymorph, salt and co-crystal screening, solid form selection, amorphous dispersions, preformulation and process development. Expert solid-state CRO in Italy.
- [Polymorph Screening Services](https://www.pcl-rm.com/rd-polymorph-screening/): Polymorph screening for pharmaceutical APIs: discover, characterize and rank crystal forms. XRPD, DSC, TGA, DVS. Independent CRO in solid-state chemistry, Italy.
- [Co-crystal Screening Services](https://www.pcl-rm.com/rd-cocrystal-screening/): Co-crystal screening for APIs with poor solubility or stability. Coformer selection, mechanochemistry, solution and slurry routes. Solid-state CRO in Italy.
- [Salt Screening Services for APIs](https://www.pcl-rm.com/rd-salt-screening/): Salt screening and selection for pharmaceutical APIs: counter-ion choice, salt formation, characterization and stability. Independent solid-state CRO in Italy.
- [Solid Form Selection Services](https://www.pcl-rm.com/rd-solid-form-selection/): Comparative solid form selection for pharmaceutical APIs: dissolution profiles, stability under ICH conditions, physical form ranking. Solid-state CRO in Italy.
- [Amorphous Solid Dispersion Services](https://www.pcl-rm.com/rd-amorphous-dispersion/): Amorphous solid dispersion development for poorly soluble APIs: polymer screening, spray drying, physical stability and crystallization risk. Solid-state CRO, Italy.
- [Preformulation Studies for APIs](https://www.pcl-rm.com/rd-preformulation-studies/): Preformulation studies for pharmaceutical APIs: physical, mechanical and chemical characterization, excipient compatibility, stability. Solid-state CRO in Italy.
- [Process Development & Crystallization Optimization](https://www.pcl-rm.com/rd-process-development/): Crystallization and synthesis process development for APIs: scale-up from grams to kilograms, in-situ monitoring, robust and transferable procedures. CRO/CDMO Italy.
- [Route Scouting & Process Impurity Synthesis](https://www.pcl-rm.com/rd-route-scouting/): Synthetic route scouting and re-design for complex molecules, plus isolation, characterization and synthesis of process impurities as reference standards. CRO Italy.
- [Formulation Compatibility Program](https://www.pcl-rm.com/rd-formulation-compatibility/): Drug–excipient compatibility, process stress and solid-form stability in the mixture: chemical and solid-state evidence before the formulation is fixed. CRO, Italy.

## Analytical services
- [Analyze](https://www.pcl-rm.com/analyze/): GMP analytical services for pharmaceutical APIs: XRPD, DSC, NMR, ICP-MS, ICH method validation, structure determination. FDA inspected, HPAPI up to OEB5.
- [cGMP Analytical Testing for APIs & Finished Products](https://www.pcl-rm.com/analyze-cgmp-analyses/): GMP analytical testing for raw materials, APIs, intermediates and finished products. AIFA-certified laboratory, FDA inspected, HPAPI up to OEB5. CRO in Italy.
- [Analytical Method Development & Validation (ICH)](https://www.pcl-rm.com/analyze-method-development-validation/): Analytical method development, validation and transfer following ICH guidelines: HPLC, UPLC, GC, LC-MS, dissolution. GMP laboratory, FDA inspected. CRO in Italy.
- [API Characterization & Quality Control Laboratory](https://www.pcl-rm.com/analyze-quality-control/): Full solid-state and analytical characterization of APIs and finished products: XRPD, DSC, TGA, SEM, SSNMR, particle size, DVS, BET. GMP laboratory in Italy.
- [Structure Determination & Absolute Configuration](https://www.pcl-rm.com/analyze-structure-determination/): Crystal structure determination and absolute configuration of chiral APIs by single crystal XRD, synchrotron, neutron diffraction and MicroED. Solid-state CRO, Italy.
- [Dissolution & Solubility Studies](https://www.pcl-rm.com/analyze-dissolution-solubility/): Dissolution and solubility studies for solid form selection and preformulation: thermodynamic solubility, intrinsic dissolution, biorelevant fed and fasted media. Italy.

## CDMO services
- [CDMO](https://www.pcl-rm.com/cdmo/): Contract development and non-GMP manufacturing, from development batches to kilogram scale. Kilo-lab 50 L, in-situ monitoring, spray drying, robust scale-up.
- [Process Scale-up & Kilo-lab Production (non-GMP)](https://www.pcl-rm.com/cdmo-process-scale-up/): Non-GMP scale-up from grams to kilograms in a 50 L kilo-lab: robust, transferable processes with consistent crystal form and bulk properties. CDMO in Italy.
- [Controlled Reactor Platforms for Crystallization & Synthesis](https://www.pcl-rm.com/cdmo-controlled-reactors/): Automated and jacketed controlled reactors for reproducible API crystallization and synthesis across development scales, with full parameter control. CDMO in Italy.
- [In-Situ Process Monitoring & PAT for Crystallization](https://www.pcl-rm.com/cdmo-in-situ-monitoring/): Process Analytical Technology for crystallization: real-time particle size, supersaturation, chemistry and thermal events. Data-driven process design. CDMO in Italy.
- [Filtration, Drying & Spray Drying of APIs (non-GMP)](https://www.pcl-rm.com/cdmo-filtration-drying/): Downstream isolation for APIs: filtration, washing, drying and spray drying for amorphous dispersions and engineered particles. Characterized solids. CDMO in Italy.

## Documents
- [White paper: crystal forms, salts and co-crystals](https://www.pcl-rm.com/downloads/PCL-White-Paper-Solid-Forms-EN.html)
- [Capability statement](https://www.pcl-rm.com/downloads/PCL-RM-Capability-One-Pager-EN.html)
- [Company brochure](https://www.pcl-rm.com/downloads/PCL-Brochure.html)

## Get started
- [Contact](https://www.pcl-rm.com/contact/): Contact PCL Research & Manufacturing — CRO/CDMO expert in API solid-state chemistry. R&D lab in Medicina (BO), Italy. Phone +39 353 4388305.
- [Non-GMP Sample Submission](https://www.pcl-rm.com/sample-submission/): Non-GMP sample submission form: quotation code, product, customer details and contacts. Submit your samples to PCL Research & Manufacturing.