Eminence Group

In the early 2000s, I was a junior project manager on a major pharmaceutical initiative. The task was twofold: develop the active ingredient for a new epilepsy drug called Gabapentin and construct a dedicated manufacturing facility. For any project manager, this was the ultimate “Triple Constraint” challenge: managing scope, schedule, and budget under immense pressure.Our…

When most people think of India’s pharma exports, they picture pills made for the U.S. or Europe. But the real story of growth today lies in emerging markets like Africa, Latin America, and Southeast Asia. These regions are transforming from peripheral destinations into strategic battlegrounds for India’s pharmaceutical giants. With soaring demand, rising healthcare access,…

If you work in generic pharma portfolio management, chances are you spend epic amounts of time locked up with a spreadsheet the size of a small continent. Molecules and dosage forms, therapeutic areas, sales channels, market shares, LoE dates, patent minefields to traverse, bioequivalence complexities, API costs and dossier suppliers, capacity constraints and on, and…

William Shaksphere once said, “What’s in a name?”. He meant to tell us that the true essence of something can never be captured by just its name.While that certainly applies to people, the case is not necessarily the same for medicines. Have you ever wondered why medicine names are so complex and difficult to pronounce,…

Reinforcing the Importance of PV and ADR ManagementWhat are the odds of getting killed by a cough syrup? For most of us, this sounds impossible. Yet, this has become today’s reality. More than 20 children in India have died not from a deadly disease, but from a spoonful of cough syrup given for the flu.…

Artificial Intelligence (AI) and tools like ChatGPT have become the defining forces of our era. From boardrooms to classrooms, from manufacturing to personal assistants, their influence is undeniable. Yet, as with any transformative technology, the story is not one-sides, it carries both immense benefits and looming threats.The three images- the original picture, the Ancient Greek…

One of the main barriers to adopting Computer Software Assurance (CSA) is the established culture surrounding Computer Systems Validation (CSV). For an extended period, validation teams have frequently associated compliance with documentation volume; larger validation packages have been seen as indicative of compliance. As a result, professionals familiar with producing and reviewing detailed test scripts…

As someone who has spent many years working across different regions and regulatory environments, I can say that the pharmacovigilance (PV) landscape in the Rest of the World (RoW) is quite complex and diverse. Unlike the US or Europe, where regulations are well-established and enforcement is consistent, many countries in the RoW are still developing…

In the rapidly evolving field of pharmacovigilance, maintaining a robust Quality Management System (QMS) is critical, not only for ensuring regulatory compliance and safeguarding patient safety, but also for driving continuous improvement. With over two decades of experience in drug safety and clinical research, I’ve learned that the success of a QMS is not solely…