Main Subject - Business

The very foundation of outsourcing means getting someone to handle your work, a partner in business. Ideally the outsourcing consultant or company shoul

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

d have a similar vision as yours and solid work ethics.

Success in business would depend greatly on finding the right outsourcing company and for this

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

Examples of combination products may in

you must:

• Determine clearly what your core business competencies are. Know your strengths and weaknesses.

• Clearly define your goals, future busine

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

ss plans.

• Create an outsourcing proposal that outlines your objectives as well as needs. State clearly the details of the project, expectations, time

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

lines, as well as budgets.

• Do in depth research on outsourcing companies to find out which ones will satisfy your needs. Alternately one can hire a c

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

Combination pro

nsultant to carry out the search.

• Search for an organization that can source many talents. Flexibility in operations is crucial.

• Interview at leas

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

t 3-4 organizations. Check out their referrals and projects completed. Be sure to meet key personnel to gauge their competencies. And check out their te

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

chnological expertise.

• Do a cost effectiveness study as also how the selected company will fulfill your needs. Whether their infrastructure and train

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

ing will be in synchrony with yours. Systems must be compatible. The costing should address impact of increased flexibility, difference in productive an

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

d time management, which is the time taken to reach the market and its effect on competition.

• Study thoroughly the non-financial costs as well as adv

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

ntages of outsourcing.

• Check with local chambers of commerce like the California chamber of commerce at www.calchamber.com or other associations that

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

Following aspects would a

focus on human resource like the Sacramento Area Human Resources Association at www.sahra.org.

• Before making a final choice check whether the outsou

dd to the challenges in developing combination products:

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

rcing company or vendor is trustworthy, find out what kind of security measures they use, check the company’s reputation in the market; determine in no

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

uncertain terms whether they have the right qualifications.

• Seek answers to: are they an established and financially sound company; what is their cus

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

tomer service philosophy; what is their service record; who are their current clients; is their estimate transparent or are there any loop holes; are th

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

y limited or can they expand along with your growth; is there an implementation plan; what about disaster recovery mechanisms; can they deliver?

• Chec

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

Professional from academic institutions, pharmaceutical industries, health care indust

k whether communications will be smooth and trouble free and if there are any cultural differences between you and the vendor. If yes will you be able t

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

o bridge the difference.

The cornerstones of a good and ideal outsource is a company that will enhance your performance; partner you in growth by infus

.

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

ing talent and technology; will share your visions; and contribute positively.

Interview the companies. After you select one discuss in detail the cont

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

Companies that provide selfless information through particip

ractual terms. Be sure to protect your own interests well. It takes trust, collaboration, communication, and chemistry to make an outsourcing successful

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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