Analytical testing – Our team conducts a series of scientific assessments to ensure the quality, safety, and efficacy of the materials used in clinical trials.

Raw material characterization and sourcing – Our expert team thoroughly evaluates the physical and chemical properties of all raw materials, while also identifying and selecting reliable suppliers.

Cleaning development and validation – Our documented process ensures the manufacturing equipment is thoroughly cleaned to guarantee the safety and efficacy of the trial drug.

Formulation development – We use our nanotechnologies to design and create the specific drug form to ensure it is stable, safe, and delivers the desired dose to participants while considering the route of administration and patient acceptability.

Pilot batch manufacturing – We conduct a small-scale production run before full-scale clinical trial production to test and optimize the manufacturing process and assess product quality.

Scale-up – Finally, we increase the production volume of a drug substance or drug product from a small laboratory scale to larger manufacturing scale.

Method development and validation – Our process creates and scientifically proves that our analytical method is suitable to accurately measure the concentration of a drug substance or product within clinical trial samples. The result is reliable and consistent results.

GMP batch manufacturing – We strictly adhere to GMP/cGMP guidelines, ensuring consistent quality, safety, and efficacy of the drug throughout the manufacturing process.

GMP release testing with QC release - Quality control tests according to GMP/cGMP standards are performed and certified by  QA.