Advice You - Business

Quality control in franchising companies is paramount and all franchising companie

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

s must have strict guidelines to insure consistency. To insure this takes place th

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

Examples of combination products may in

oughout your franchise system you must make this a policy in your confidential ope

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

ations manual. Your first step should be to make an outline of your policies and r

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

easons behind them, since you might need help getting started please feel free to

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

Combination pro

rint this article and modify the outline below to best fit your specific business

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

nd vision for your company.

Next sit down with a legal pad and a pen when you hav

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

e some quite time and write out several paragraphs for each item. Once completed w

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

th this task you have a workable rough draft. Type it up and make copies for the b

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

ardroom. After various other ideas and concepts are kicked around make a couple of

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

revisions and have it properly formatted and type set with cool graphics. This fin

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

Following aspects would a

al copy should become Gospel and your new company mantra. Trust me on this, you ne

dd to the challenges in developing combination products:

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

d a quality control manual and policy that everyone can grab hold of. Think on thi

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

.

QUALITY CONTROLS

I. OVERVIEW

A. Insuring Repeat Business

B. Strong Reputa

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

tion

C. Supplies On Hand

D. Word Of Mouth

E. Franchisor’s Guidelines

II. A

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

EA REPRESENTATIVES

A. Help You Watch Managers

B. Field Complaints

C. Set Up

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

Professional from academic institutions, pharmaceutical industries, health care indust

onus Programs (Employees)

D. Refresher Courses On Site

E. Break In New Employee

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

s

III. FRANCHISOR

A. Direct Mail Program

B. Franchisee Contract Renewal

C.

.

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

Training Crews

D. Designated Representative

IV. EQUIPMENT MAINTENANCE

V. TIM

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

Companies that provide selfless information through particip

LINESS

VI. SERVICE

A. Same As Quality

B. You Can’t Have One Without The Othe

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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