Blog

Let’s be honest: pharma submissions can feel like a bureaucratic endurance test. Mountains of data. Endless formatting rules. And then, just to make life harder, you’re hit with three acronyms—CTD, eCTD, ACTD,  all promising to be the “right” way to submit. Here’s the truth: choosing the right dossier format isn’t optional. It can mean the […]

Pharma looks like a gold mine from the outside. High margins, blockbuster drugs, global demand—it’s one of the most lucrative industries in the world. But here’s the catch: it’s also one of the toughest markets to crack. New entrants face brutal pharmaceutical market entry barriers: high investment demands, strict regulations, and an industry dominated by […]

In pharma and life sciences industry, market research is conducted to collect and analyse data that helps in making clinical, commercial, and regulatory decisions. One of the most important practice you can follow while conducting pharma market research is to focus actual and real-world dynamics rather than just working on assumptions. This blog is a […]

After helping over 1000s of companies, here’s what we have understood- no medical device fails in labs, it fails in the market. The reason is simple, companies do not understand their market, their consumers, regulators and other stakeholders. Sometimes, the product solves the wrong problem, sometimes technology becomes obsolete by the time it is launched, […]

Companion diagnostics are very important in precision medicine as they identify patients who can be treated with particular therapies, therefore enabling personalized treatment approaches. In Australia, the regulation of companion diagnostics has undergone a remarkable evolution, making it at par with global standards to ensure safety, efficacy, and innovation. This blog analyzes the regulatory environment […]

Overview The pharmaceutical industry is one of the most regulated sectors globally, ensuring that drugs are safe, effective, and of high quality. To maintain compliance with stringent regulations, companies must undergo frequent audits and adhere to industry standards. This article delves into the audit and compliance process in the pharmaceutical industry, emphasizing the importance of […]

Introduction In today’s highly regulated pharmaceutical industry, regulatory compliance audits are more important than ever. With the increasing complexity of global regulations, pharmaceutical companies must ensure they meet the required standards to avoid penalties, protect their reputation, and remain competitive. Regulatory compliance audits serve as a critical tool in achieving these goals, and working with […]

The biotech and pharmaceutical industries are at the forefront of groundbreaking innovations, improving healthcare worldwide. As new technologies, regulatory changes, and evolving consumer needs continue to shape these sectors, the future of biotech and pharma manufacturing holds tremendous promise. By understanding the key trends, businesses and stakeholders can adapt to the changes and ensure they […]

In the ever-evolving world of the pharmaceutical industry, safety is a top priority. Pharmacovigilance (PV), which refers to the detection, assessment, understanding, and prevention of adverse effects of drugs, plays a crucial role in maintaining patient safety and improving drug efficacy. One of the most powerful tools in the realm of PV is the pharmacovigilance […]

India’s Knowledge Process Outsourcing (KPO) industry has undergone a remarkable transformation over the last few decades, positioning the country as a leader in the global outsourcing landscape. Known for its highly skilled workforce, cost-effectiveness, and extensive industry expertise, India remains the go-to destination for outsourcing services, especially in areas such as finance, healthcare, legal services, […]