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When the time comes to start hiring staff, a lot of entrepreneurs fail to give much thought to all the responsibilities that come with being an employer. The average small-business owner isn’t equipped with either the knowledge or the time to comply

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

with the mountain of regulations required by the government. Fortunately, HR outsourcing--hiring a PEO to oversee your HR tasks--is a solution that not only provides help with compliance issues but can also provide assistance that’s tailored to you

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

Examples of combination products may in

r company’s specific needs.

A PEO, or Professional Employer Organization, can offer HR solutions tailored to small and midsized businesses in all industries. For an annual fee, usually 2 to 7 percent of the dollar value of your annual payroll,

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

PEO will take care of everything from recruiting and hiring to managing your health benefits. Since many smaller businesses can’t afford to hire an HR professional, PEOs can be a cost-conscious option. For instance, if a company has a $1 million pa

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

yroll, a PEO can provide the equivalent of a full HR department for roughly $20,000 to $70,000 a year, considerably less than a fully staffed HR department or even one qualified executive.

Generally, a PEO will legally hire a company's current

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

Combination pro

employees, thereby making the PEO the "employer of record" for taxation and insurance purposes. Having the employees of multiple businesses “on staff” allows PEOs to enjoy lower benefits’ costs because more employees mean better rates. The employees

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

are then leased back to the original employer (now a PEO client) under a shared-employment contractual relationship, which sets out the powers, responsibilities and liabilities of the parties. This practice is also known as “employee leasing” or “st

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

aff leasing.”

The PEO then assumes responsibility for all payroll obligations, workers’ compensation coverage and tax filings. Additionally, health, welfare and retirement benefits can be contracted as well as all associated administrative work

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

. Because they take over most of the headaches of being an employer, PEOs are ideal for small businesses. In fact, most PEOs target companies that have 150 employees or less.

Many times, a PEO arrangement is the only way a small business can of

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

er benefits like health insurance, dental and vision care, life insurance, retirement saving plans like 401(k)s, Section 125 cafeteria plans (flexible spending accounts for healthcare and childcare), job counseling, adoption assistance and education

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

al benefits. Most small businesses just couldn’t afford or manage these benefits on their own.

Finding the Right PEO for Your Company Ideally, a PEO will relieve its client companies of the time-consuming and money-draining bu

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

Following aspects would a

rdens associated with HR. Because PEOs offer many different types of services, choosing the right PEO is essential. If you’re thinking about hiring a PEO for your business, consider the following factors to find the best possible PEO arrangement to

dd to the challenges in developing combination products:

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

eet your needs:

-Conduct a basic needs analysis. Lay out exactly what type of HR and risk management concerns your company has.
-Review the services of all the PEO firms you’re considering. Find out which firms can meet all your needs and

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

will do so in a manner that meets--if not exceeds--your expectations.
-Perform extensive background research to find out if the PEOs’ sales pitches are really what they deliver.
-Check out the companies' staff. Does it have the depth and

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

expertise to deliver on its promises?
-Find out how the firms deliver their services. In person? By phone? Via the web? A mix of all three?
-Determine what kind of consulting the PEOs provide on strategic HR issues like recruiting, HR proc

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

dures and processes.
-Ask for a few references, and then check them. If a particular PEO can’t relieve your HR burden, one of the other ones certainly can.
-Find out if the PEOs charge any upfront fees and how those fees are determined.

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

Professional from academic institutions, pharmaceutical industries, health care indust

What about pre-payments? Do you have to put up a deposit?
-Ask for some demonstration that payroll taxes and insurance premiums are being paid properly, and that any past clients’ legal issues have been correctly and efficiently handled.

O

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

nce you’ve selected the PEO you’ll be hiring, lay the foundation for a lasting relationship with your PEO by meeting the people you’ll be working with face to face. An open line of friendly communication ensures you won’t be lost in the in-box.

.

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

The bottom line is, PEOs can help small and midsized employers enjoy the same HR benefits as large companies without the considerable overhead. A PEO costs less than hiring an internal HR employee and will maintain critical employment records and p

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

Companies that provide selfless information through particip

ayroll reports, as well as provide the forms needed to make sure you’re in compliance with all required employee regulations. Being an entrepreneur is difficult enough without all the accompanying HR hassles, so find a PEO for your company today.

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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Remember that the miracle of cloning sheep has its drawbacks. The main one--dying young. Don't let your business die young by following the herd. Instead, think of the natural ways you like to market. Here are three Marketing Ideas that Make Big Promises. And, when followed by investing a large amount of money and time, only a few will get the results they hope for.

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