At PCL Research & Manufacturing we offer a complete range of analytical capabilities to support your requirements. Our highly qualified scientists operate in top-class laboratories fully furnished with state-of-the-art equipment. Our laboratories have been inspected by FDA, are GMP certified by AIFA and are authorized to the handling and study of HPAPIs up to OEB5.
Our laboratories are authorized by the Italian Ministry of Health for the study, production and analysis of controlled substances and are equipped for the handling and full cGMP analysis of highly potent APIs up to OEB5 — with dedicated containment, segregated workflows and strict handling protocols at every step.
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 (API), intermediates and finished products.
PCL Research & Manufacturing has a proven record of excellence in developing analytical methods throughout the entire drug lifecycle. Our approach follows ICH guidelines, including preparation of validation protocols and reports to be shared and agreed with our clients.
The validation of each method will meet your quality needs at each development stage, providing cost-effective solutions.
Material science in pharmaceuticals requires the expertise to evaluate each API using a variety of techniques. At PCL Research & Manufacturing we can support the characterization of your APIs and finished products using Polarizing Light Microscopy (PLM), Scanning Electron Microscopy (SEM), Differential Scanning Calorimetry (DSC), Thermogravimetric Analysis (TGA), Particle Size Distribution by light scattering and X-Ray Powder Diffraction (XRPD). Our capabilities go well beyond this list:
Knowing exactly how a molecule sits in the crystal lattice — and which enantiomer you are working with — underpins patent protection, regulatory submissions and process understanding. PCL Research & Manufacturing determines the three-dimensional structure of your solid forms and assigns the absolute configuration of chiral APIs, combining X-ray, neutron and electron diffraction techniques.
Each technique answers a different question. Together they cover the full range of samples encountered in drug development — from well-formed single crystals to sub-micron powders that cannot be grown any larger.
The experience and knowledge in pharmaceutical dissolution within PCL Research & Manufacturing focus on supporting preformulation studies and solid form selection. Dissolution testing is never a routine test — it is a highly customized, essential tool in pharmaceutical development.
We evaluate the physico-chemical properties of drug candidates to select the most appropriate solid form for further development (pre-formulation), and perform biorelevant in-vitro tests to mimic fed and fasted state conditions and compare prototype formulations (preclinical selection).
Our team of expert chemists and analysts is ready to support your drug development — from early-phase screening to non-GMP development and manufacturing.