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In today’s transient and fast paced world, it’s getting harder and harder to find qualified, competent people who not only know their stuff but can be trusted to handle your business’s monies. All too often you hear stories about inexperienced

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

so called bookkeepers who either messed up someone’s books or stuck their hand in the cookie jar and helped themselves to thousands or millions of dollars.

Exact Accounting Services has listed 7 of the most important things you need to know

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

Examples of combination products may in

hen making a decision to hire the right bookkeeper, permanent or contract. Like everything else in life, there are no guarantees but by following our guide, you can help reduce the odds of inviting the elephant to come sit on you.

Our goal is

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

to keep this list short and sweet and not to make this sound like a Jerry McGuire movie mission statement. Here are the 7 things you need to know in order to find the right bookkeeper. Good luck!

1. The Experience Factor - Do they really kno

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

their stuff? There is an awful lot of competition out there, given that, people will say the darndest things to land that job. The objective here is to not be a guinea pig for someone who needs to improve their accounting skills. If you want

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

Combination pro

o reduce your chances of hiring a dud, go with a reputable firm. They’ve done all the work for you plus they have a track record but if you want to go it alone, here are some questions to ask:

How long have they been doing bookkeeping? Do the

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

y have an accounting background? What accounting software programs have they worked with? Are they tech savvy? What type of companies have they performed bookkeeping services for in the past? Can they provide references? References are extreme

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

y important. Try to get at least 3 references.

2. Trust - Can you trust them? Always know who you’re dealing with! This could not be said enough. Do they come across as honest and sincere? Whether you’re using an outside firm to hire your boo

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

keeper or going it alone, always perform a thorough background check, even if they were referred to you by someone you know. When having a background check performed, you want to check criminal, social security number and credit information al

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

ong with drug testing. After all, this person is going to be controlling the future of your company by handling all your monies. Scary thought isn’t it? Understand this, even if that person passes the background check with flying colors does n

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

t guarantee theft and wrongdoing due to the fact that people change and their lives change. The best way to stay in check is to become educated and always keep tabs on what they’re doing. There are certain things you can do to keep an honest p

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

Following aspects would a

rson honest by having checks and balances in place.

3. Reliability - Are they reliable, dependable and responsible? Did they call when they said they would call? Did they show up when they said they are going to show up? Do they return your c

dd to the challenges in developing combination products:

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

alls in a timely manner? You’d be surprised how many people fall through the cracks on this one. If they fail anyone of the above, you can be assured the same types of problems will apply to your books.

4. Personality – This is very important

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

Do you feel comfortable with them? Are they easy to work with? Do you feel there might be personality clashes? All the skills in the world will not make up for a temperamental artist. No one wants to be working with the Soup Nazi. You need to

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

be able to approach them no matter what.

5. Communication Skills - Like anything else in life, business involves people skills. People skills involves communication skills. Money is the life line of your business. Anyone handling your busines

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

s’s monies must be able to communicate with you 100%. If there is a problem, you need to know ASAP! No ifs, ands or buts. If they have a better way of doing things, they need to be able to let you know.

6. Integrity and Character – You want s

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

Professional from academic institutions, pharmaceutical industries, health care indust

meone who is not only loyal and passionate about what they do, you want someone who has high moral values and standards. As mentioned above, accounting can make or break your business so it is crucial to have the right person handling your boo

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

s.

7. Trust Your Gut – You know that feeling deep down inside. If something doesn’t seem right, trust your instinct. Sometimes that’s all you have to go on. It’s amazing how many people do not trust their instincts and go against their better

.

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

judgment. The bottom line is, if it doesn’t feel right, don’t do it!

Remember, you can always outsource your bookkeeping to a bookkeeping service but just because someone else is managing your books for you doesn’t exclude you from understan

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

Companies that provide selfless information through particip

ing accounting basics. Checks and balances also need to be put in place to help keep honest people honest. One of the greatest advantages of having someone else manage your books is that you now have more time to focus on growing your business

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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