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Current business situation shows that to outsource means to benefit, i.e. to make profit from international trade in products and services. Witnessing high quality companies th

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

at have helped to improve the global perception of the "brand", lots of producers have stuck to the idea of partnership with offshore development teams. Participating in such b

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

siness does not necessarily take away from them market share, but it is a 100% key factor in maintaining customers and acquiring new business i.e. providing a quality product

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

or service.

To run business above and beyond the limitations of production methods is essential nowadays. No doubt, this task is not an easy one taking into conside

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ation that companies try to keep inventories low, overhead costs and capital expenditures to a minimum.

Being not able to keep up with the upgrade of technological adv

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

nces, nor the expense of keeping employees up with these improvements, most companies start to use outsourcing as on of the essential ways to upraise any product or service o

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

e has to offer.

According to statistics, more than 85% of companies participating in IT development business and outsourcing abroad, usually do it in CIS countries:

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

half of that number takes risks to establish ODC (Offshore Dedicated Center) that allows to benefit from the expertise of another company, without accumulating the expenses of

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ew equipment and training.

An ODC is a dedicated, customized, and secure development center established for a customer that needs to outsource application and maintena

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

ce work for a long period of time. ODC model gives the customer better control over the process of product development, and helps to have higher resource efficiency (cost savin

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

up to 70%).

Being a branch of offshore business, Dedicated Center does not require any up-front investments or long-term commitments: the company chosen handles i

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

corporation issues, establishing IT infrastructure, legal fees, payroll, legal compliance and office leases. Being not obliged to pay office expenses, internet, electricity, in

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

rastructure and many more, the employer can be sure that each dedicated member of this team works 180 hours per month making profit.

With companies all over the world

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

veryone can gain access to talented engineers, experienced developers and trendy designers. Leveraging the dedicated team means that customers who risk can handle their own IT

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

rojects quickly and efficiently, utilizing cost-effective equivalent in-house resources.

At the same time, management team that is a must in every modern IT developme

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 company is always at client’s service to provide a level of convenience and security that one would never get by working within some local development departments.

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

With roots in all continents and countries, IT development companies are utilizing close relations with local universities, the development community and educational centers to

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

quickly fill the need for qualified engineers. Local business connections also work for outsourcing companies’ benefit.
ODC BENEFITS:

1. Focus on Core IT Compete

.

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

cies - Save on Cost of Applications Development
2. Avoid Long-term Investments
3. Lower Business Risks
4. Best Practices from Leading Web Development Company

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

5. Quick Return on Investment
6. Full Operational Control
7. Established IT Infrastructure
8. Access to the Best Talents
9. Improved Product Release Time

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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