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If you were given the task of setting up a new Human Resource Department in a small company where would you begin? Such a task would be extremely daunting, but not imposs

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

ible, if you follow a few tips. To begin, you need to answer some basic questions:

Why do you want to set one up? What’s changed to make you or the organization believe

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

Examples of combination products may in

that an HR department is needed now? What do you want the HR department to do? How will this function contribute to the success and bottom-line of the organization? Will

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

it add value?

In other words, before you begin the task, you need to have a clear definition of the mission and goals of the department and secondly, what role you will

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

play as “head” of the HR function. Once you have clear direction, there are some key “audit” issues that you need to focus on.

Do you have personnel files on all your em

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

Combination pro

loyees? Are they current? Do you have all the legally required documentation? Do you have items in the files that don’t belong there?

Do you have policies and procedures

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 they up-to-date? Are they followed? Do you have an employee handbook? Do you have the right language in it? Have you inadvertently created a contract between you an

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

d your employees? Do you have policies dealing with ADA, EEO, FMLA, sexual harassment, workers’ compensation, safety, benefits, discipline, etc.?

Are you in compliance w

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

ith state and federal regulations? Do you have a working knowledge of the law? Do you have all the required postings, forms, and documentation required by the respective

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

governmental agencies? Are all the managers aware of their legal responsibilities and liabilities?

Are you recruiting and selecting the right people? Are you aware of th

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

talent and skills needed to move your organization forward? Do you know where to find these people? Are you recruiting in a cost effective manner? Are your managers trai

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

Following aspects would a

ned in interviewing techniques?

What kind of compensation plan do you have? Is it meeting the organization’s needs? Is it motivating your employees? Is it competitive an

dd to the challenges in developing combination products:

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

d fair? How about your benefits? Are you getting the best coverage for your people at a price the employees and the organization can afford? Is your total compensation at

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

tractive enough to retain existing people and be an incentive to new people?

What’s it like working at your company? Are people productive and motivated? Are you looking

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

at the indicators of a productive and motivated workforce (absenteeism, tardiness, turnover, grievances, high workers’ compensation rates, poor quality, missed deliverie

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

, and poor productivity)?

What about your training? Are manager’s and employee’s skills current? Is training a “way-of-life”? Are you growing your people or do you have

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

Professional from academic institutions, pharmaceutical industries, health care indust

to go to the outside every time you need someone with a specialization? Are supervisors effectively managing their employees?

Are managers and employees kept informed? D

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

o they know what’s going on? Is the grapevine the main source of communication? What are the sources of communication?

Obviously it is impossible to make a complete guid

.

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

e of things you need to consider when starting a new HR department in a small company. However, these are some of things you should consider. As you begin the process, ge

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

Companies that provide selfless information through particip

t some professional help, whether through networking with peers, other organizations, or outside expertise. It is a big task, but one that is critical to the organization

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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Discount futures brokers are a viable option, as long as you thoroughly examine all of the futures discount brokers that you are interested in doing business with. Choose a discount futures broker that has an outstanding reputation and a good customer service department. Although saving money is nice, you often have to look beyond the money saved.

Envelope manufacturing is a widely established fraternity. Since envelopes are in great demand all over the world, there are many companies in the business. Each one of them strives to produce the best, most useful, and most creative envelopes for attracting customers great and small.

To stay competitive in the marketplace a business needs to be cost effective. All businesses run via processes and Business Process Management (BMP) is a technology developed to give businesses the framework in which to manage more effectively the processes that make them tick.

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