Top Adding - Business

Yeah, sure it's easy, and of course, that title is a little tongue in cheek. It takes a lot of hard work to get a business off the ground. But, it's worth every hour I've spent getting to where I am now.

When I decided to start my communication and image consulting business, I tried hard to find a good startup guide. I couldn't find any that had all the steps. So, I decide

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

d to write one. So far, it's mostly just the bare-bones outline (which is long enough as it is) you see in this article.

I'll be adding to it every week or two, and writing more detailed articles on all the steps, so try to stop by and check it out from time to time. Let me know how I'm doing. Shoot off an email to me if I've forgotten something or you have questions.

Bef

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

Examples of combination products may in

re you spend so much as a dollar, talk to a few experts. Go to the library or get on the internet and research, research, research. Take a little time to make sure entrepreneurship is right for you.

Make a pro and con list of business ownership, and evaluate yourself honestly. How many characteristics do you have in common with successful entrepreneurs? Is your financi

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

l position strong enough? Do you have the necessary technical and management skills?

You’re not going to be the perfect entrepreneur. Nobody is. But in order to make yourself the best entrepreneur you can be, consider ways to compensate for any weaknesses you might have. I’m from Canada, so the government agencies I’ve mentioned in this guide are Canadian, but really

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

it can be used by anyone.

All you have to do, if you’re from somewhere other than Canada, is find out where you need to find some of the things I’ll talk about. Some of the steps might be slightly different, and you may not have to worry about things like GST for example, but I’m sure you’ll find this discussion helpful all the same.

These steps to starting a business ar

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

Combination pro

e in reasonably good order, but you might find yourself varying from it under your particular circumstances. That really isn’t a big deal, as long as you get most of it done. There are some steps you’ll be able to skip as well, but please don’t skip any of the “big ones”, which I’m sure you’ll pretty much figure out from taking a look at the list.

So, assuming you’ve done

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

our evaluation and you still want to start a business, take a deep breath, and let's get started.

Conduct a feasibility study of your business. Describe your typical customer, your product and your competitors. Who will your suppliers be? What will you charge for your product? How will you market your product? These are just a few of the questions you need t

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

answer.

Write a complete business plan for your company, using the information you gathered from your feasibility study. This vitally important, often overlooked step needs to include a description of your company, its goals, competitors, market, financial information, and of course, how you intend to meet your goals.

Get your financing in place. Th

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

re are many ways to finance your business, from your own savings to personal credit cards to bank loans. If you need credit, know your business plan from front to back and maybe even sideways.

Decide what kind of structure your company will have. From a legal standpoint, there are three basic choices, sole proprietorship, partnership and incorporation, each

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

with advantages and disadvantages.

Choose a name for your company and check on name availability. Naming your company is highly individual, but it’s the first thing associated with your business, so choose your name carefully. You’ll need to do a NUANS (Newly Upgraded Automated Name Search) report, which checks your name choices for uniqueness against a databas

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

of other business names. A reserved name is valid for 90 days.

Decide whether you want to register federally or provincially and register your company. If you register federally, you’ll also have to register provincially, which almost doubles the cost. You don’t have to have a lawyer process them for you, but it might be a good idea to at least consult with o

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

Following aspects would a

e. You can get the forms from your local government office, have them faxed to you or download them. You can fax or email printed copies, or complete the forms online.

Contact Canada Revenue Agency Business Window for your business number, and to register for GST/HST, payroll, corporate income tax and import/export (if applicable). You can also contact the CR

dd to the challenges in developing combination products:

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

if you need general information about business expenses. Chances are you’ll have to collect GST, but you may want to register for a GST number even if you don’t have to collect it because of input tax credits.

Decide whether you need to collect PST. If you do, you need to submit “Registration as a Vendor” documents with your province.

Determine wh

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

ether there are special permits or licenses in your municipality. It’s highly unlikely that your municipality does not have special permits or licenses.

Develop the marketing materials you decided on in your business plan. They should include at least a company identity package, press kit and website. Your identity package is your logo, business card and lett

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

rhead. A press kit can include letters of introduction, biography sheets, press releases, articles and a brochure. In today’s electronic age, printed materials aren’t enough. You need a website that looks professional, matches your printed material and has great copy. You’ll also want to make sure it’s optimized for search engines.

Set up your business bank

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

ccount and record-keeping system. Your banker will need to see your incorporation documents, and you should probably set up more than one account so you can keep track of your finances better. Record-keeping is required, and can be done manually or with a computer program.

Purchase insurance. There are many different types of insurance, but most probably your

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

Professional from academic institutions, pharmaceutical industries, health care indust

company will need at least one. For example, if you’re going to have employees, you need to contact the Worker’s Compensation Board. Depending on your type of business, you might want to contact them even if you don’t have employees to insure yourself.

Contact potential creditors and set up credit terms. You should have researched suppliers when you were doin

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

g your feasibility study. Now is the time to contact them.

Decide where your business will be located. Lease your business’ space. Alternatively, you could choose to start your business from home if it’s feasible. There are advantages and disadvantages to starting your business from home. You have tax write-offs for example, but sometimes your image suff

.

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

rs.

Purchase supplies and office equipment. You’ll need too many things to list here, and of course, each business has different needs. You might need a fax machine and printer. You’ll probably need a computer. You’ll definitely need paper, pens, pencils and a calculator.

Congratulations! Go out, buy yourself a bottle of champagne and celebrat

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

Companies that provide selfless information through particip

. You're about to embark on a most exciting journey. And may I be the first to wish you good luck and prosperous times in your business venture.

As promised, my email address is listed below so you can ask questions, make comments or add steps to my list. Or, if you want, you could just drop me a line to let me know how your small business is doing. I’d really like to know

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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Your interview is coming up and you are feeling very confident. You've thought through how your personal presentation will sound and you are ready to go. You are confident that you have anticipated the questions they might ask you and have prepared some great answers. You know what questions you need to ask them. Clean copies of your CV or resume are sitting in your briefcase. But before you go any further, you'd better ask yourself these questions and be sure you manage the visual impact:

Once considered an unacceptable option to the career-minded, underemployment has become increasingly common as more professionals find themselves out of work for extended periods of time. You need a job and the optimum one is not on the horizon. The key is to be flexible. Taking a step down doesn't have the negative impact on one's career that it used to have. Nor does changing jobs with regular frequency. Climbing back up the career ladder is commonplace in today’s volatile employment market.

One of the single most important pieces of information you need when buying a business -- any business, big, medium or small -- is the truth about why the owner(s) is selling the business. What's the real reason.

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