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Jumping into the pharma market without good intel is the same as driving blindfolded, you might move fast, but you’re headed straight for trouble. Companies that skip this step often face delays, failed launches, or completely miss big market shifts. That’s where pharmaceutical market intelligence comes in. Think of it as your radar: collecting and […]

Bringing a drug to market isn’t a science problem—it’s a systems problem. Regulators don’t care how groundbreaking your data is if the paperwork’s sloppy. Miss a detail, and you’re looking at months of delay, runaway costs, or a hard stop. Here’s the thing: the right guidance flips the game. This isn’t theory—it’s a field manual. […]

Biosimilars are changing the game in pharma, but let’s be real—getting them approved isn’t simple. Unlike generics, you can’t just copy the recipe and call it a day. There’s a lot of comparability studies, detailed clinical data, and perfectly aligned regulatory paperwork. That’s where regulatory affairs consulting services comes in the picture. And here’s the […]

You’ve built a promising drug candidate, but one overlooked patent claim can sink your launch. Patent landscaping is not a box to tick. It’s your strategic radar, showing where others have staked claims and where white space exists. A proper landscape maps granted patents and pending applications across jurisdictions. That intel exposes crowded zones, filing […]

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 […]