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Are your people consistently following your procedures? Each year, organizations lose thousands of do

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

llars through common mistakes and lapses in usability. But what does that mean for business owners an

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

Examples of combination products may in

executives?

Ask yourself:

• Are your required actions described thoroughly and accurately,

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

or are the details left open to interpretation?

• Is your content consistent and complete, or are yo

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

r writers leaving gaps no one has noticed?

• Are revisions controlled, or are different people using

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

Combination pro

different versions?

• Are your procedures compliant with regulations? Are you sure?

• Are all docum

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

nts written to produce clear, measurable results?

If you're unsure about any of the answers to these

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

questions, there is good news: you can make your procedures clear and complete without combing throug

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

all of them yourself line by line. You have invested in your procedures; now ensure you are communic

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

ting clear expectations, and your professionalism, with the best tools possible.

Strengthen Your

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

anagement Procedures’ Documents

With a technical writing review, professional technical writers

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

Following aspects would a

can review and edit your documents. Methodologies have been developed and used by experienced technic

dd to the challenges in developing combination products:

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

l writers to strengthen policies and procedures, so you can put efficiency and expertise to work savi

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

g you time and hassle. You can eliminate the costly professional headache of poorly written managemen

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

procedures.

Get the Help and Reap the Rewards:

• Easy upgrades to your documents

• Increa

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

ed clarity for your written procedures

• Expert objective commentary on your documents

• Fast resul

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

Professional from academic institutions, pharmaceutical industries, health care indust

s to model other procedures

• Convenient tech writers at your service

• Detailed grammar and langua

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

e correction

If your policies and procedures are incomplete, outdated or inconsistent, then you are

.

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

robably not driving the performance improvement you intended. But no matter what your worst procedure

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

Companies that provide selfless information through particip

headache is, you can eliminate your lapses in usability now and improve to “best practices” standards

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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