Development of new drugs and control of pharmaceutical manufaturing are complex processes that require accurate analytical studies. The pharmaceutical development cycle passes from the discovery in which the candidate active pharmaceutical ingredient is identified to the preclinical development in which the active ingredient must be characterized and the formulations must be developed and characterized. The subsequent stages of toxicological studies and clinical studies ensure that the drug is safe and effective. Finally, in production the quantity of material produced is increased and critical process parameters and critical material attributes must be monitored to ensure batch consistency.
Several issues related to development projects, drug safety, manufacturing, market demands for evidence-based data and increased regulatory requirements can be overcome through a better understanding of the pharmaceutical product and manufacturing process.
Alfatestlab offers a complete range of analytical capabilities and services to support pharmaceutical industry and other related markets such as medical devices, cosmetics and homeopathic products. Alfatestlab has great expertise and experience in particle, powder and dispersion analysis. As a result of our understanding of materials we can support our customers in testing from product development to manufacturing process. Our portfolio of analytical methods includes many of the techniques required to meet the quality standards for successful drug development:
- Active pharmaceutical ingredient and excipient chemical-physical characterization
- Stability studies
- Quality control of finished product
- Contamination identification
- Bio-equivalence assessment in vitro
- Biosimilarity assessment in vitro
- Affinity & Kinetic Characterization
Alfatestlab ensures the accuracy of the analytical methods used for customers projects and in addition offers:
- Development and validation of analytical methods
- analytical method transfer
- optimization of existing methods
For any analytical project, Alfatestlab offers effective communication, using frequently scheduled phone conferences, on site face-to-face discussions and exhaustive reports.
Contact us to discuss your analytical needs.