Main Subject - Business

Business has finally started to pick up. Things are not steady, but instead you find at times that you have too many orders to fill or too many projects to complete. You can’t afford a steady employee, or even a part time employee (or yo

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

u don’t want the hassle of IRS), but you don’t want to continue working from 6 am-10pm at those busy times. What do you do?

As a small business owner, I have found the best solution is to have some reliable well trained subcontractors on

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

Examples of combination products may in

your “team.” When I first opened my Virtual Assistance business, I had 3 well qualified people approach me that they were interested in work, if I ever had enough. I had them sign a contract, provide me with their tax information, and to

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

d them IF I ever had work for them, I would be in touch. Since, I have used them several times, which has helped my business to grow. Here are some tips to help you get started using a subcontractor:

-Find subcontractors BEFORE you need

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

them. Don’t wait until you get that first project or order, and then you are scrambling to find someone to help you, because chances are if you find someone, they won’t be the quality you desire.

-Check references. Just because they are

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

Combination pro

subcontractors, doesn’t mean you should trust they will do quality work. They are representing your business, and you need to ensure that you aren’t going to spend more time cleaning up their messes, then you would if you had just done th

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

project yourself.

-Get all your paperwork in place BEFORE you need them, and let them know you will be in touch when you have work. This way you are not scrambling to get paperwork back, the project out, etc.

-Have a contract, and make

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

sure there is a no compete clause in it. Sometimes it is necessary for you to give out your clientele information to your subcontractor, and it is necessary for them to contact your clientele, depending on the work. Make sure they are al

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

ays representing your company and understand they may NOT discuss future projects with the client and their company.

-Agree up front on the pay, and get it in writing. Also determine how and when you will pay them. I have heard various

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

iscussions on paying your subcontractor immediately or waiting for client payment. I think this depends on your company and what you can do. I have subcontracted my services out, and have worked for people who pay upfront, and people who

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

pay when they get paid. In both cases, I had a written agreement, and was comfortable with the agreements. Decide what you can do, and find subcontractors who are quality and agree to your terms.

-Always be clear on the amount you will

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

Following aspects would a

ay them. You do not have to share how much the client is paying you and how much you are making off of it. Be fair to yourself and the contractor. You put time & money into landing the client, overseeing the project, and getting payment

dd to the challenges in developing combination products:

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

from the client. You need to ensure you are compensated for that time, money, and effort. Also, realize the subcontractor is doing the work, saving you a great deal of time, and using their own time, so be fair to them and pay them well.

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

If someone is not paid well, they probably won’t do the quality you want, and they won’t work from you again. Deciding what to pay is your own decision.

-Have in writing exactly what you expect from your subcontractor. If they will be

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

oing the same thing every time, make sure they have a copy at all times, and you have a copy signed on file. If they will be doing different things with each project, then for EACH project, give specific details and have them sign a copy

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

or your records. This way if there is dispute on how the project was completed, you have the paper that was signed.

Working with a subcontractor can be a wonderful, profitable experience for you. You can continue to grow your business,

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

Professional from academic institutions, pharmaceutical industries, health care indust

nd take on projects you would not otherwise be able to do. Additionally, you are not required to give them work and if they don’t do a quality job for you, you don’t have to give them anymore work. Just remember to respect your subcontra

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

tor and treat them with dignity. They are not someone to be looked down on, but someone who is saving you time and money. They deserve to be treated with respect.

This article is only a general outline of working with a subcontractor, a

.

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

d is not meant to be the only information you use in decision making. I did a ton of research on contracts and the uses of subcontractors so that I was comfortable in my role as the “supervisor” and knew what to expect. I have had only w

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

Companies that provide selfless information through particip

nderful experiences and am sure you will also.

© 2005 JERPAT

You have permission to reprint this article electronically or in print, as long as the text and byline remain unedited. A courtesy copy of your publication would be appreciated

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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From my experience, I've been on many discussion groups and have spoken to many other like minded people. The one topic that always seems to arise is how to get massive sales right away. Not only mas...

How is your job hunting going? Have you had problems finding legitimate jobs? I don’t know if you’ve ever thought about using freelance websites to obtain work at home, but this should be something you look into. It might not be for you, but you never know until you try.

HUD-1 is a standard form you use very often. The form serves not just as a settlement closing statement, but also as a proof of payment of different tax deductions. Understanding the form and the tax deductible items and communicating them to your clients will help your clients to minimize their taxes and help you to build trust and get more business exposure.

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