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Data without integrity is just data Systems compliance strategy  according to Data Integrity and Software Selection in QbD PTM Consulting developed a methodology to support companies to build appropriate Data Integrity strategies, with a new  approach, integrated to the company Quality System and based on sound risk analysis and management, according to the principles of the Q9. Systematic and versatile, the methodology  can be used during the design phase of…

Risk Assessment for Reagents and Solvents Optimize the management of reagents and solvents within laboratories. Since 2014, many companies have decided to use this service to verify their proper management in daily use of their laboratories; PTM Consulting, a leading company in Life Science, applied its long lasting experience in risk management and innovation attitude to create a new service: Risk Assessment for Reagents and solvents. This  service provides a…

QbD: New EMA Guideline on Manufacture of the finished Dosage Form The EMA published its new Guideline on Manufacture of the finished dosage form. The new EU guidance will help applicants in preparing marketing authorization dossiers and in what to include in Module 3 of their common technical document. This guideline will update the previous guideline “Note for Guidance on Manufacture of the Finished Dosage Form” that was originally adopted…

PTM Consulting attended one of the most important american event for Durg Delivery. For 21 years, DDP has been the world’s largest drug delivery meeting place to accelerate drugs to market and lengthen lifecycles for long term profitability by finding new partners, new drug delivery technologies, and new formulation development strategies. One of the hot topic concerned the impact of new technologies on medical device. The Digital Health that merges…