Main Subject - Business

Image is so vitally important to a franchising companies brand-name, that each and every franchisee mus

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

t maintain consistency of appearance in their franchised outlets. This means that maintenance and repa

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

Examples of combination products may in

ir of the business location must be up to standards of the confidential operations manual of the franch

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

ised business at all times.

If a franchised outlet is in the state of disrepair and looks it, but cust

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

mers will know and it will be difficult for them to maintain consistency and quality in the goods and s

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

Combination pro

ervices they perform and provide. It is for this reason that every franchisor must pay specific attent

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

ion to this detail. Below is a clause I put into all of our franchise agreements to address this issue

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

;

3.18 Maintenance and Repair

3.18.1 Maintenance and Appearance of Business Location

Franchisee must

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

maintain the condition and appearance of the Franchised Business in a manner consistent with The Car Wa

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

sh Guys System image. Franchisee will perform all maintenance that is reasonably required from time to

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

time to maintain the condition, appearance and efficient operation of the Franchised Business, includin

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

Following aspects would a

g replacement of worn-out or obsolete fixtures, equipment, signs, supplies and inventory, repair of the

dd to the challenges in developing combination products:

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

interior and exterior of the premises and periodic cleaning and decorating. If at any time in the Franc

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

hisor’s reasonable judgement the general state of repair, appearance or cleanliness of the Franchised B

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

usiness does not meet Franchisor’s standards, then Franchisor will give Franchisee written notice speci

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

fying the action to be taken by Franchisee to correct the deficiency and Franchisee will initiate the r

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

Professional from academic institutions, pharmaceutical industries, health care indust

quired action immediately upon receipt of the notice.

--- ---- ---- ---- ----

as a franchisor you wou

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

ld be well advised to talk with inexperienced franchise attorney about the maintenance, repair and appe

.

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

arance of the franchisee in their business location and be prepared to address this issue not only in t

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

Companies that provide selfless information through particip

he confidential operations manual but also in the franchise agreements. Consider this to those experts

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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