We offer support in the development, industrialization, optimization and validation of pharmaceutical processes in accordance with the reference standards (DOE, FMEA, QbD, PAT, ICH q8/ q9/ q10, ASTM, ISO). Identification of the QCA (quality critical aspects), reduction of costs, improvement of the efficiency of processes
feasibility of studies and process scale-up.
We also elaborate protocols for the validation and maintenance of the status (prospective, concomitant and retrospective validation).
We offer companies consulting services, including staffing, in the development of new formulations (generic or new drugs) and in the optimization of the parameters: pharmaceutical form and dosage, compatibility between active substances and excipients and between excipients, optimization of formulations, physicochemical properties of the product, biological interactions (bioavailability), shelf life, manufacturing stability and development of the target product profile (TPP). Furthermore, we develop and validate new test methods in accordance with ich\q2\q8, optimization of test parameters (accuracy, precision, robustness, etc.), compliance with new pharmacopoeias.
- Development, industrialization, optimization and validation of pharmaceutical processes in accordance with the reference standards (DOE, FMEA, QbD, PAT, ICH q8/ q9/ q10, ASTM, ISO), with on-going reports;
- Elaboration of protocols for prospective (prior to the marketing of the product), concomitant (during normal production) and retrospective (for consolidated processes that have been operational for some time) validation also in support of the DMF (Drug Master File);
- Validation status maintenance protocols;
- Process Validation Reports (Reports of data collected during the validation process);
- Medium-term reports (Interim Reports);
- Identification of CQA (Critical Quality Aspects);
- QRM (Quality Risk Management);
- Literature research oriented towards the design of the scientific research;
- Patentability assessments;
- Interpretation of test results;
- Development of a manufacturing process that constantly provides the desired pharmaceutical formulation with the adequate physicochemical properties;
- Study of the physical properties of the solid (e.g. shape and size of the particles, stability, ease of drying, filterability, solubility, dissolution rate, etc);
- Formulation design;
- Determination of the compatibility of the excipients;
- Development of drug production strategies suitable for the properties of the drug;
- Development of test methods for the specific pharmaceutical form.