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Consumers in the United States spend almost seven trillion dollars each year on consumer goods. In order to tap into this lucrative market, many major companies manufacture

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

their products in exotic locales such as China, India, or other Asian nations due to their cheap labor and lax trade restrictions. Unfortunately, few of the industries that

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

Examples of combination products may in

xport their capitol across the Pacific realize that they could save more money with one short trip across the southern border to the maquiladoras of CaliBaja based in Mexical

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

i, Baja California and Calexico, California.

Because of international trade agreements such as NAFTA, manufacturers can import raw material and heavy equipment into Mexico d

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

ty and tariff-free in an arrangement referred to as the maquiladora program. The word maquiladora is derived from the Spanish term that translates to “to submit something to

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

Combination pro

the action of the machine.” The governments of the United States and Mexico developed a mutually beneficial economic partnership that allows American businesses to utilize

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

exican labor laws while maintaining production standards and levels found in the best American factories. This agreement has been the secret weapon used by such prominent co

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

mpanies as 3M Corp, General Electric, Boeing, Sanyo, Wolf Electronics, and Page Electric to decrease production costs and increase profits.

CaliBaja is the leading business

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

n the maquiladora program. Clients from across the United States employ CaliBaja in one of two ways: the contract system and the shelter system. The contract system requires

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

the least amount of risk on the client’s part, for it allows them to concentrate on running their business and leave the manufacturing to us. We handle everything else, from

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

quality control, inspection, maintenance, and shipping, to production scheduling, translation, training, and documentation management. Basically, clients tell us what they wa

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

Following aspects would a

nt to make, we make it, and pass along our expenses as cost. Depending on the volume and type of item desired, clients could save tens of thousands if not hundreds of thousa

dd to the challenges in developing combination products:

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

ds of dollars.

The shelter system is the fastest way to get a product out the door and to the shelves of retailers. Under this production design, the client provides the eq

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

uipment, tooling, technical experience, quality control, and management, and we handle the permits, taxes, government interaction, accounting, and legal representation. Cali

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

aja also ensures that our clients have the finest workforce drawn from the highly motivated and educated population of Mexicali. Furthermore, many clients often find that ne

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

ither of these solutions fits perfectly with their business needs, so CaliBaja can tailor a program that can suit any manufacturing situation.

Partnering with CaliBaja has s

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

Professional from academic institutions, pharmaceutical industries, health care indust

veral distinct advantages over not only international production but also other maquiladoras in Mexico. First, because we are located next to the U.S.-Mexico border, our cli

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

ents have more direct control and oversight into their production process, with no time difference commonly experienced during trans-Pacific manufacturing. Furthermore, our

.

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

acilities are serviced by major rail lines, roads, deep water shipping ports, and airports that can distribute products throughout America and the world. Mexicali is also a

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

Companies that provide selfless information through particip

prime location for manufacturing, as other border locations such as Tijuana lack both the infrastructure and workforce to properly staff a sophisticated manufacturing program

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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Once an entrepreneur has grown from working in his basement or garage to having employees the question about benefits will ultimately rise. That leaves small business owners in cross roads between spending money on benefits and spending money on growth.

If you are thinking of getting into the medical billing industry, you might want to read about some common on the job problems you are bound to run into. Doing so may just save your life.

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