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Advice You - Can I Do It All Myself?
Sometimes we feel that we are handling everything just fine. You’re a business owner and your list of clients is growing leaps and bounds as you hoped it would. The money is coming in and you may even enjoy s 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 pending an extra hour or two at the office to get caught up at the end of the day or early in the morning before the phone begins to ring. This is how you wanted it but if only you had those one or two extra ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in hours every day. The new blackberry is fine but you know you need a back up at the office 'just in case'. Your growing stack of business cards is piling up in an ever-tightening rubber band in your desk draw lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. r and you promise yourself that you'll be organizing them into some sort of filing system 'one of these days - soon.' The promotional letter and the mailing list you were going to do on Tuesday will just here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe have to wait a few more days because an out-of-town client unexpectedly called and needs some of your time. You've lost the whole day but you don't mind because it's part of the job - reshuffling and reschedul d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro ing other clients and duties is a normal part of the business and you have to keep your priorities in order - after all, you do care about giving your best and it's the client who keeps the money coming in. 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 While you're at the client you remember one more thing that has you distracted from the matters at hand. You were supposed to call and make an important lunch appointment with a 'potential' client you've bee 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 n hoping to get and it completely slipped your mind. As you sit, you feel sure you left the name and phone number of the restaurant the client suggested on a slip of paper on your desk. This week isn't going nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically quite as well as it should - 'those days' are becoming 'these weeks' are they are happening too frequently lately. Business is growing but things aren't being done in the timely manner they used to be. 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 ou're now losing ground in other important areas and so the once well-oiled machine is showing a bit of a strain. Instead of focusing on your clients, you're becoming bogged down with administrative office dut ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi ies and they're piling up fast and furious. You lost the piece of paper, Wednesday appointments didn't get rescheduled on time, the database isn't being maintained and the invoices haven't been sent out - not ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a to mention all the daily correspondence that isn't being taken care of. On and on it goes. If only there was an extra hour or two in your day just to finish things up without distractions. Somewhere in dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod our mind you remember clicking on a website that provides these services - some kind of an assistant over the internet that helps out and you don't have to pay for more than what work is done - even down to te cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin n minute increments. As you jog your memory you remember some of the words you're - Connected Virtually to an Office Assistance - or something to that effect. You probe your mind a little deeper and you remem tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen ber the words Virtual Assistant. You type the search and see they already have office machines and software and they're experienced professionals. Instead of wondering how you'll get caught up, you conta 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 t a Virtual Assistant and tell her what you want done. Suddenly your burden has become lighter and you feel the tension leave and you're focused again. All you need to do is fax, email or upload files and you ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust r VA takes it from there. In a short time the meeting has been set up, old appointments were rescheduled, a reservation was made and you get reminders from you daily planner. Your VA calls you with any un y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products expected changes that have arisen or are anticipated and she has booked your business trip to the west coast next month - even finding a better price on the airfare and hotel, so you actually saved money. Now . 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 you're undivided attention is given to the client and you can increase your business potential. You sigh with relief knowing that you need never feel like things are getting ahead of you again. As an adde elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip d touch, your VA called you later to see how the meeting went - you tell her you got the client. Your Virtual Assistant congratulates you then smiles as you both hang up the phone. Both have had a good day. 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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