Useful Advices - Business

Looking at today’s businesses, the business owner and their management team, I see many challenges, issues and opportunities they face every d

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

ay. In fact, I help the owners and their management teams deal with business challenges, issues and opportunities, as a strategic thinking bu

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

Examples of combination products may in

iness coach. Let’s see if you are dealing with any of these challenges, issues or opportunities by answering the following questions:

Are yo

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

dealing with any of these business challenges, issues or opportunities?

1. Would you like to work “ON” your business, instead of only workin

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

g "IN" YOUR business so that you can run your business on a “hands free” approach and gaining more personal time?
2. Do you need help ge

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

Combination pro

ting organized?
3. Do you need assistance in creating systems and processes for your business?
4. Do you need assistance in establ

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

shing a succession plan for your business?
5. Do you need more capital to operate your business?
6. Do you need assistance in de

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

veloping a strategic plan, a strategic action plan and goals and objectives to reach your vision?
7. Do you need assistance in developi

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

g strategic marketing plans?
8. Do you need assistance in reviewing and recommending changes to your business model to become more profi

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

able?
9. Do you need assistance in grooming a successor and an exit strategy so you can realize a monetary reward for your risks in busi

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

ess?
10. Do you need assistance in actually seeking venture capital or other forms of financing growth of your business?
11. Do y

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

Following aspects would a

ou need assistance to improve your personal performance in your business?
12. Do you need a confidante and trusted independent voice to

dd to the challenges in developing combination products:

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

urn to for counsel when you face challenges issues and opportunities?

My professional experience tells me that you most likely answered,

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

YES” to a few or to many of the above questions. Okay, you have admitted to being faced with business challenges, issues and opportunities.

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

So at? Well, there is very good news for you. Strategic thinking business coaching can and does help entrepreneurs, and business owner and t

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

eir management teams meet challenges, resolve issues and take advantage of opportunities. Strategic thinking business coaching is a very powe

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

Professional from academic institutions, pharmaceutical industries, health care indust

ful tool that will help you:

1. Expand your vision and give you insights into the operation of your business
2. Create a Strategic Pl

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

an, along with a Strategic Action Plan and related business plans
3. Lead & develop your team through improved communication, leadership

.

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

nd management skills to higher performance levels
4. Identify strengths, weaknesses, opportunities and threats through a SWOT analysis

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

Companies that provide selfless information through particip

> 5. Develop the plans, tools and systems to deal with the SWOT results and to achieve the defined vision and goals and objectives.

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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