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Our team in Bulgaria is available to assist English – speaking buyers in person, showing

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

properties, areas and providing valuable information about the country and its residentia

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

Examples of combination products may in

l tourism market. We work with English-speaking lawyers and leading banks to assist our c

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

lients during the purchasing process, whose main characteristics can be summarised as fol

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

lows:

• The total purchase cost should not exceed 5 %( including lawyer’s fees), except

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

Combination pro

in the case of older and/or cheaper properties.
• Under Bulgarian law a foreigner ca

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

nnot own land. If you wish to buy land or a house with a plot you can circumvent this law

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

by forming a Bulgarian company through which you can legally own the property. However,

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

you do not need to form a company to purchase an apartment.
• We advise buyers to a

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

lways use a lawyer

The purchase process consists of the following steps:
• A reserv

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

ation deposit is paid to hold the property – usually 1,000 Euros.
• If the property

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

Following aspects would a

consists of land or an existing re-sale property a Bulgarian company must be set up thro

dd to the challenges in developing combination products:

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

ugh which it can be legally bought and owned.
• An initial private purchase contrac

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

t is signed (after having been thoroughly checked by your lawyers) and an initial payment

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

is due – usually about 10% to 40%, depending on whether it is a re-sale or off-plan prop

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

erty.
• Stage payments are paid throughout the building process for most off-plan pr

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

Professional from academic institutions, pharmaceutical industries, health care indust

operty.
• The Notary Act is then signed in front of a Bulgarian notary. In the case

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

of an off-plan development, the Notary Act is signed once the building is completed.

The

.

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

time scale of each of the steps depends upon the type of sale. In the case of an off-pla

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

Companies that provide selfless information through particip

n development, the preliminary contract is usually signed within weeks of the reservation

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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Answers - Buying Process In Bulgaria

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