The Indian pharmaceutical industry has been inundated by a substantial number of regulatory inspections, especially from US Food and Drug Administration (US FDA) and other prominent regulatory authorities such as UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and Health Canada. The challenges arising here may be daunting but the emphasis has been to steadily … More Building the base for ‘good’ data integrity
The Indian pharmaceutical sector has been growing exponentially over the last few years. According to India Brand Equity Foundation (IBEF), it accounts for close to 2.4% of the global market in terms of value terms and 10% in terms of volume. IBEF also states that the sector is expected to grow at a Compound Annual … More Dealing with the data integrity dilemma
Sustainable profitability is vital in today’s highly competitive business environment. This factor has therefore prompted companies to devise strategies that are in sync with this aim. While profitability has essentially always been a focus, ensuring its existence for the long term is a goal which requires a heightened level of efficiency. This can only be … More Fraud: it is costing you!
The Indian pharmaceutical sector has seen immense flux in recent times in the form of stricter regulations, price control, contract manufacturing, mergers and acquisitions and foreign investments among others. Regulators around the globe, such as United States Food and Drug Administration (US FDA), the United Kingdom Medicines and Healthcare Products Regulatory Agency (UK MHRA), World … More Weathering the trials of quality and data integrity compliance in the Indian pharmaceutical sector