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Outsourcing is transferring business processes from one company to another. The concept is to have the management or day-to-day execution of one or more business functions pe

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

rformed by a third-party service provider who is already in sourcing those same business processes. A parent company uses the outside firm to provide a business function 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

could have been done in-house. The aim of outsourcing is to make the business or organization more competitive by staying focused on its core competencies.

Benefits of outso

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

urcing:

• The company functions on a continuous or ongoing basis rather than on any specific single project.
• It enables companies to focus on their core business func

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

ion. Outsourcing takes care of ancillary functions in part or in totality. This optimizes the company’s growth based on its core or specific business.
• Reduces operati

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

Combination pro

g costs by focusing on major business area. This way, the capital funds always remain available for the core business instead of being diverted to other supporting portions o

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

f the business.
• Improves productivity and service by standardizing all operations and processes across your global portfolio. The outsourcing vendor manages your glob

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

l portfolio comprehensively, thus increasing the lifespan of your portfolio.
• Outsourcing when taken off shore gives you access to world-class capabilities. You can lev

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

erage global resource networks to support your business. It gives you another perspective or dimension to the existing business for more efficiency.
• With the shrinking

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

world and cross-culture across the world, it helps employees to assimilate efficiently in changing the working environment.
• It fosters and sustains an exceptional safe

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

y culture, emphasizing training and employee morale.
• If done on same premises/country, it provides an alternate career option to employees.
• Creates flexibility

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

Following aspects would a

with the facilities to even provide support in times of industry uncertainty.
• Speeds up work, shares innovations for best practices. You can maintain competitive edge

dd to the challenges in developing combination products:

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

ith new ideas.
• Reduces risk and increases productivity.
• Frees many resources for other purposes for enhancing or expanding your business in other directions.

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

> • Companies can save 10-20% cost on an average with outsourcing.

Additional Benefits of outsourcing:

• Renewed focus on core business.
• Improved customer satis

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

action with improved processes.
• Risk reduction due to reliance on experts and infusion of new technology.
• Project enhancement and effective cost management thro

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

gh financial engineering.
• Renewed opportunities for employees with skill upgrade and access to newer skills.
• Visible cost reduction and avoidance of capital inv

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

Professional from academic institutions, pharmaceutical industries, health care indust

estment.
• Asset conversion.

Value derived from outsourcing facility management

• Value and savings gained. This occurs during initial transfer from in- to outso

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

rce as they do the job much more cheaply because of the availability of huge manpower and similarly larger global business.
• Increased focus. The management time and re

.

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

sources previously used on managing the facility can be used for research and development projects.
• Increased flexibility. It can eliminate fixed overheads and physica

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

Companies that provide selfless information through particip

plant ownership, thus cutting costs.

Outsourcing, besides cutting costs, can build a virtual large company with a large work base with the entrepreneur as the sole employee

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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