Research and development are two fundamental and strategic elements within every company because they allow for the constant innovation of products, solutions and processes. We know how crucial they are, which is precisely why we manage them in the best way we can.
Our experience comes from the pharmaceutical world: a real training school. Today, we apply our skills to bring real, added value to the different sectors in which we operate: Finance, Banking, Insurance, Fashion, Hotel & Restaurant and many others.
m-Squared consulting offers support and expertise in the development, industrialisation, optimisation and validation of processes, in accordance with the reference standards (DOE, FMEA, QbD, PAT, ICH q8/ q9/ q10, ASTM, ISO) of the different sectors.Identification of the QCA (quality criticality), reduction of costs, improvement of process efficiency, feasibility of studies and process scale-up, and development of protocols for the validation and maintenance of their condition are additional services that we take care of, constantly aware of every detail.
SERVICES OFFERED IN THE R&D AREA
- Development, industrialisation, optimisation and validation of pharmaceutical processes according to the reference standards (DOE, FMEA, QbD, PAT, ICH q8/ q9/ q10, ASTM, ISO) with ongoing reports;
- Development of prospective validation protocols (before marketing the product), concomitant (during normal production) and retrospective (for long-established processes) also in support of the DMF (Drug Master File);
- Validation status maintenance protocols;
- Process Validation Reports (Reports on the data collected during the validation process);
- Medium-term reports (Interim Reports);
- Identification of CQA (Critical Quality Aspects);
- QRM (Quality Risk Management);
- Bibliographic research directed towards the design of scientific research;
- Patentability assessments;
- Interpretation of test results;
- Development of a production process that consistently provides desired pharmaceutical formulations with adequate physico-chemical properties;
- Study of the physical properties of the solid (e.g. particle shape and size, stability, ease of drying, filterability, solubility, dissolution rate, etc.);
- Design of the formulation;
- Determination of the compatibility of the excipients;
- Development of drug production strategies adapted to the properties of the drug;
- Development of test methods for the specific dosage form.
