Getting Busier…


Just letting everyone know that I will be writing and posting less in upcoming months.

I have a lot of things going on professionally, which are very exciting but same time I can not keep up with all of my other engagements. I promise the next article on R&D costs will be published in early March.

Thank you for your interest and loyalty 🙂


Store, Discard or Recycle? – How to Own Your Schedule


Efficient prioritization and planning should be the two critical skills of every business professional. Planning is a process of thinking about the tasks and goals one wishes to achieve in a given time. Prioritization is a process of ranking the tasks according to their importance and focusing on those which are the most critical or have the biggest potential impact on your goals. Proper planning and prioritization facilitate your and your team success. Continue reading

Do Not Panic: How to Achieve Inspection Readiness

pills-1569173_1920-copyInspection Readiness (IR) is a proactive process. It is a process of ‘getting ready’ for an inspection by a regulatory authority (such as FDA), which is conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority to be related to the clinical trial.  Continue reading

Risk Management in Drug Development


Risk Management is the continuous process of identifying, analyzing and responding to risk factors throughout the life of a project. The risk management starts at the beginning of the project and continues throughout the life of the project. At each stage of the project’s life, new risks will be identified, quantified and managed. Proper risk management is proactive rather than reactive and reduces the likelihood of an event occurring and the magnitude of its impact. Reactive risk management is often called as crisis management. The right balance in risk contingency is necessary; too much may make the project uncompetitive; too little contingency increases the chance of failure. Risk management is a responsibility of the project team and is driven by the project manager. In short, risk management is about anticipating uncertain events that are inherent to a project to optimize them for project success. Continue reading

Know the Pharma Basics: Drug Development Plan


Drug development can be described as the process of obtaining the relevant information necessary to be included on your drug prescribing information. Development Plan (DP) is the strategic document that guides the lifecycle of a new product from the pre-clinical lead compound stage through Lifecycle Management (LCM). LCM starts with the first approval of BLA/NDA (first Marketing Authorization) and encompasses development of new indications. In mature pharma organization, DP is approved by the governance bodies. Once approved, it can be regarded as the agreement between executive leadership/board of directors and the program team involved in the discovery, development & commercialization of the product. The DP is a living document and should be amended when the development strategy changes. Continue reading