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Hiring employees is a huge responsibility. Before hiring anyone, be sure to carefully analyze your needs in terms of extra assistance.

Once you’ve gotten through the hiring pro

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

cess, there’s still much more you must do now that you’ve become an employer. If you’re like most small business owners, you just don’t have time to do all you’re supposed to

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

Examples of combination products may in

e doing when it comes to managing your employees.

The article aims to outline five steps you can take right now to better manage your employees. Failure to complete these steps

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

may one day lead to trouble for your business – trouble that could easily have been avoided.

Step #1 – Publish a Company Handbook

Most employers do nothing more than chuckle a

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

the mere mention of a company handbook. Who has time for such frivolousness? Besides, no one reads them anyway. If these are your thoughts, then think again. Make time to cre

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

Combination pro

te a company handbook and then make every employee read it. Also have every employee sign a statement saying that they have read the handbook. Place the signed statement into

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

heir personnel file where it will remain should you ever need it.

Step #2 – Create Files for Sensitive Employee Data

You will have a lot of employee-related documentation to kee

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

track of and you must have a place to store it all, safely, and away from prying eyes. Payroll information, health insurance information, certifications including expiration

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

ates, performance reviews, and kudos from happy clients as well as negative comments from clients or supervisors are just some of the documentation you need to maintain.

Step

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

#3 – Create a Schedule

If you operate a business with “normal” business hours and just a few employees, you might think that creating a schedule is unnecessary. But unless ther

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

is a schedule, you can only assume that your employees know when they need to show up to work. Creating schedules is a good habit to get into, especially if you plan to have

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

Following aspects would a

lot of employees on your payroll. Create a work schedule for your employees and put it where they will see it.

Step #4 – Perform Periodic Employee Evaluations

Employee evaluati

dd to the challenges in developing combination products:

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

ns or performance reviews tend to be more important to the employee than they are to the employer. Employees want to know how they are doing and when they’ll be eligible for a

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

pay increase. There are so many reasons why it’s important to complete employee reviews, including legal ones. An employee review is one of the few things you have, in writing a

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

d signed by employee and employer, that clearly describes an employee’s performance on the job. Should you ever need to let the employee go or take other action, you’ll have 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

is documentation to back up your decision.

Step #5 – Keep a Safe Work Environment

Sure you need to keep your fire exits clearly marked and free of clutter. But there are Feder

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

Professional from academic institutions, pharmaceutical industries, health care indust

l and state laws with which you must comply covering everything from the storage of hazardous chemicals to the posting of bulletins in common areas where employees congregate.

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

Comply with these regulations before you end up on the losing side of a lawsuit.

Properly implementing these five steps seems like a lot of work especially when you have little

.

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

spare time. One way you can manage your employees and still have time to do all your other tasks is to purchase software that has been designed to help manage employees. Spend

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

Companies that provide selfless information through particip

ng the time and money to better manage your employees now will keep you from spending even more time and money later on, after you’ve been hit with an employee-related lawsuit

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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