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Digg It - Good News for a Growing Problem
Whether you are in Hardware, Garden Products, DIY, Housewares, or are a Builders Merchant, contract packing provides ‘Good News’ for a growing problem. As an increasing num 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 ber of buyers improve margins by turning their attention to imported goods, the limitations and specific dangers of this choice must be taken into consideration. Product tha ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in t is on the water for up to twelve weeks can compromise your profits if it doesn’t arrive in the desired condition, potentially causing you to lose your customers and your m lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. rket window. Furthermore, if you are importing product in bulk to save shipping fresh air, you will need to be able to process it domestically in a cost effective and timely here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe way. The Pareto principle, or 80/20 rule, in context defines that up to 20% of all such imported product will potentially need some form of attention. It will either: fail d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro Q.C. (yours or your customer’s) because it has not been packed according to specification, require re-packing domestically because it has failed some obscure customer or le 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 islative requirement, it may need re-branding or re-labeling as your market changes it’s mind, or simply be damaged in transit. You may have had it manufactured and packed 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 overseas, shipping it directly to your customers national distribution center. If it arrives with them and fails their incoming inspection, you may be in for a hefty fine, o nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically r worse, lose the customer. Alternatively, if it’s shipped directly to your own premises, you then need to employ valuable space and labour to deal with it. If the product c 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 mes from overseas, cost and time prevent it from being sent back to the source for rectification, so this must be dealt with domestically in a cost effective way. What are ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi you to do when you need to act decisively, quickly and above all cost effectively in these situations? Wouldn’t it be nice if you had the capacity that allowed you to react ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a to these challenges by utilizing the flexibility of a rapid response team dedicated to providing the packing or re-working of your products; not only that, but at the same t dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod me potentially improve your profits because the work done has been carried out on a piece rated or unit costed basis. The good news is that such a mechanism exists, and you cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin do have access to it. Out-sourcing, including co-packing or contract packing and rectification has suddenly come of age as the opportunity to improve profits through import tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen ing has grown exponentially. This has led to a sustained increase in the number of importers requiring either out-sourced packing or rectification work. Apart from the mass 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 ve savings they can make when faulty product is intercepted and redirected for rework before it hits the national redistribution center, it can benefit the customer in a thr ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust eefold way. It can save them from a hefty fine (Very Important). It can save them money by cost effective unit packing (Profit through Co-Packing). But most importantly it c y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products an save their reputation (Priceless). Whatever your market enterprise, if you are importing, you will without doubt at some time experience one or more of these situations. . 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 It is important to remember that this need not be a destructive experience. Changes to our markets have presented us with specific challenges to overcome, however if you can elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip perceive them as new opportunities to improve efficiency and profits, through the effective use of co-packers and re-workers then this really is Good News for all concerned 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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