Advice You - Business

Sifting through the Competition

In recent years, as the access to the Internet has increased significantly, the number of bric

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

k and mortar and e-commerce firms offering background checks has truly exploded. Fraud has existed for over 5,000 years, since the civ

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

Examples of combination products may in

izations of ancient Egypt and Mesopotamia, and it's been growing ever since.

Most clients today find their background check or invest

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

igative firm via the Internet. This leads us to the question: How can one sort through the pages and pages of background checks on the

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

web? Many of the investigative or background check sites are fraudulent themselves, i.e., false advertisments misleading website traf

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

Combination pro

fic, offering substandard service, and never produce any service representative of a real background check.

The search is less compli

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

cated when choosing an international background check firm. Few players are successful at obtaining results on a global level. Thus, w

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

divide our rankings into two divisions: 1) National or U.S. and 2) International or Global.

* Quality Score reflects pricing, servic

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

es, client service and cases

** Quality Score Ranking is between 1-5 (1 = excellent, 5 = poor)

National or U.S. Rankings

1. Owens O

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

nline (General, National & International, QSR = 1)

2. Wymoo (General, National & International, QSR = 2)

3. HireRight (Employment Sc

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

reening, QSR = 2)

4. Intelius (Strictly U.S., Automated Reporting, QSR = 3)

5. Kroll (Employment Screening, Corporate Service, QSR =

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

Following aspects would a

3)

6. Abika (General, National & Some International, QSR = 4)

* Results are general in nature and should give the consumer an idea

dd to the challenges in developing combination products:

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

of services and quality offered. Depending on the client's situation, additional information can be found at the Company websites.

In

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

ternational or Global Rankings

1. Wymoo (General, International 100+ countries, QSR = 1)

2. Owens Online (General, International 250

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

countries, QSR = 2)

3. HireRight (Employment Screening, 200+ countries, QSR = 2)

4. Kroll (Employment Screening, Corporate Service,

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

QSR = 3)

5. Abika (General, International 12 countries, QSR = 5)

Owens Online, while offering more than 250 countries worldwide, ea

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

Professional from academic institutions, pharmaceutical industries, health care indust

rned a lower score than Wymoo with 100 countries. Wymoo's personalized client service, wide range of services with fully customized ca

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

ses, and narrative reports boosted its ranking.

As stated previously, each of the above firms (or websites) offers a different range

.

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

of service, products, client service, investigative methods and reporting styles. These rankings should only be used to aid in the ini

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

Companies that provide selfless information through particip

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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