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This webinar aims to help you understand five critical factors in helping you sustain your GMP compliance It also aims to help you understand the criticality of those factors FDA Inspection Issues Firstly if one were to look at the last three years data on the FDA website and look at the issues
As the pharmaceutical landscape gets more competitive speedoflaunch and firsttimeright formulation development are key to achieving successful launches of new medicines while decreasing the related expenditure Reducing cost and time of development can also allow affordable and new medicines to reach more patients
India is the worlds third largest pharmaceutical generics producer with the highest number of FDA and MHRA GMPapproved manufacturing plants outside the US and Europe The challenge of remaining in GMP compliance continues to be the main concern India has seen a resurgence of breach of data integrity and quality issues
Developing and delivering an innovative modular solution for biopharmaceutical manufacturing requires knowing both the cleanroom technology and the process design of these facilities
In Pharma as in other industries were in an age where the needs and obligations of companies are evolving by the second from accelerated product cycles to keeping up with investor and government demands for Environmental Social Governance ESG metrics
Our bespoke testing and clinical service offering which covers full clinical development from Phase I firstinhuman trials to Phase II and Phase III studies in patients provides reliable and accurate results that ensure the safety of your products and protect patient health
As most readers will be aware Annex of EudraLex Volume GMPs is being updated The process has been somewhat protracted with multiple versions being reviewed updated and discardedAs most readers will be aware Annex of EudraLex Volume GMPs is being updated The process has been somewhat protracted with multiple versions being reviewed updated and d...
Fishawack Health FH is a leading global commercialisation partner for the biopharmaceutical medical technology and wellness industries FH was created to offer integrated services for pharmaceutical and biomedical development and commercialisation across four core disciplinesConsulting Medical Marketing and Value Evidence and Access
The FDA has restarted unannounced inspections of manufacturing facilities The restart commenced on February Inspections were halted in March with the outbreak of COVID A limited number of inspections had restarted however they were again paused due
Regulatory authority inspections are restarting across the world Companies can help ensure that they are ready for these inspections by utilising third party specialists to audit their facilities NSF Internationals team of exFDA MHRA and other regulatory body inspectors along with our experienced industry specialists are currently working with comp...
