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E-Folder - Going Solo as a Consultant
Does it makes sense to go solo as a consultant? Well depe According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product nding on the work you do it sure might. You see going sol ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in has lots of advantages and perks and you can choose your lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. clients, generally command a higher rate and enjoy what y here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe u do because you are choosing when and where you work. Th d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro re are huge advantages to becoming a solo professional an ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc there are too some time issues you will have to over com easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi e. Time is the make or breaker for the solo professional nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically consultant. Time can be your friend if you measure it and and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ use it wisely or it can become your biggest nightmare if ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi ou do not manage it properly. A true solo professional is ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a always thinking about time, how to use it more efficientl dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod and how to get all the work done that they have gotten t cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin emselves into. Consultants must also be sure to get paid tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen for all their time as well. All too often these supersta t? As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel solo professionals end up only getting paid for a fracti ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust n of all the work that they do and that is truly a shame. y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products But as your reputation gets more well-known and your work . As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de begins to speak for itself you bill more per job or hour elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip nd get paid what you are worth. Consider all this in 2006 tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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