With the FDA under fire in recent years regarding the quality of inspections, the effect on biotech, pharmaceutical, and medical device companies has been to err on the safe side of regulatory requirements by proving more evidence wherever they can.DOWNLOAD ARTICLE
That the pharmaceutical and biotech industry is in a state of flux is undeniable. Shifts within the U.S. marketplace have intensified the pressures on industry to perform, while the FDA has been struggling with its own charter.DOWNLOAD ARTICLE
The passage of H.R. 3962, the Affordable Health Care for America Act of 2009, has changed the healthcare landscape forever, kicking up dust in the U.S. pharmaceutical marketplace.DOWNLOAD ARTICLE
The last few years in the pharmaceutical industry have seen unprecedented upheaval, with changes to the marketplace on all fronts. In the U.S., consolidation on a massive scale amongst the elite of the industry raises new questions about competitiveness and
what it takes to keep it.
There can be no doubt that the last decade for the pharmaceutical and biotech industry has been full of extraordinary change. Regulatory changes culminating in the FDA’s 2004 guidance A Risk-based Approach to CGMPs underscored the reality that as an industry we needed to evolve.DOWNLOAD ARTICLE
As the U.S. pharmaceutical and biotechnology markets ebb and flow, one truth cannot be argued: sustainability is the provenance of companies that can adapt to the new marketplace and deliver on business performance.DOWNLOAD ARTICLE
There is an old saying that “change is inevitable… adapting to change is unavoidable; it’show you do it that sets you together or apart.”1 Looking closely at how we have developed products, defined quality assurance and demonstrated regulatory compliance, the last five
years have been remarkable in terms of coping with change.