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In Genentech received regulatory approval for Herceptin a monoclonal antibody targeting HER positive breast cancer marking the beginning of the modern personalised healthcare revolution
Todays formulation challenges are as diverse as they are demandingfrom increasingly insoluble new chemical entities NCEs to highly bitter drugs to increased regulatory emphasis on patient acceptancearriving at a final dosage form that has commercial potential is a more complex proposition than ever
India is a major hub for manufacturing and exports of pharmaceutical products
As the biopharmaceutical industry continues to push the boundaries of science Thermo Fisher Scientific is continuing to advocate for the use of new technologies workflows and stronger industry collaborations
Maintaining regulatory compliance in a global marketplace is increasingly challenging as wellestablished regulators and regional local regulators increase their digital capabilities and expectations of Marketing Authorization Holders MAHs
The figures above show the excellent position the sector is in Nevertheless there are threats to the success of the industry This webinar looks at two specific areas that threaten the industrys success and that companies need to be mindful of as we head into
As at the end of May around billion COVID doses had been administered in Asia since this unprecedented immunisation campaign began in Both here and worldwide there is no doubt that the pandemic vaccination programme has done much to raise the profile of research into and deployment of liquid pharmaceutical drugs
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
