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There have been quite a few complaints from publishers about late or non payment from distributors and book stores. Some have stopped sending books to large distributors because of past due invoice

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

s, some over 180 days old. Part of the problem is no response, it is bad enough when you are not getting paid, but when orders keep coming in and you are not getting any acknowledgement to your col

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

Examples of combination products may in

ection efforts, you just can’t keep sending books, says one publisher.

There are steps you can take to get paid on those past due invoices and keep new invoices current.

Step #1 Gather together al

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

l the past due invoices, and stamp them PAST DUE.

Step #2 If you have an email address or phone number with a contact name for your client, email them or call them and give them the information on

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

he past due invoices and let them know their account is on hold.

Step #3 Mail the invoices to your client with return receipt requested or send them in a flat rate Priority Mail envelope with deliv

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

Combination pro

ry confirmation. Using the large colorful envelope is a great way to get your information to the top of the pile. Who do you know that doesn’t grab the big Priority mail or Fed Ex envelope out of

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

their mail pile to open first?

Step #4 Send a letter with these invoices stating the age, invoice numbers, their PO#, your account #, total amount due, and any other pertinent information. You may

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

want to request a proof of delivery or print off the delivery confirmation information from the web to send with the letter.

Step #5 Tell them their account is on hold and you will not be shipping

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

any more products or providing any services to them until these invoices are paid. You can include a self addressed envelope and state that you have enclosed an envelope for them to send their chec

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

. Give them a date, to have this paid to you.

Once they have received the package, email or call them. Ask them what they are doing with the invoices. Ask them questions such as:

Do they have to

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

be approved by someone else?

If they have to be approved, who has to approve them and when will they give them to that person? Get that person’s direct number if possible. Find out if that person s

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

Following aspects would a

igns the checks. Are there any discrepancies with the invoices? When will the check be cut? When can you call back for the check number?

Once all the past due balances are cleared up, you need to

dd to the challenges in developing combination products:

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

think about future invoices. Do you want to extend credit again or do you want to have pre-payment or payment at the time of the order. Whatever you decide put it in writing. If you can both sign

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

the agreement, that is even better. Remember, having a credit policy in place tells people you mean business.

Some authors will only ship on a pre-paid basis to bookstores or distributors they ha

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

e had payment problems with. It is up to you to decide is it worth it to keep shipping books when you are not getting your money and then having to spend time (which is money!) chasing your money?

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 it worth losing the money to have your book out there and being seen by someone? Most small publishers and authors are desperate for a sale or for interest in their books, and usually that is ho

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

Professional from academic institutions, pharmaceutical industries, health care indust

w they end up in this situation. It is my opinion that distributors and book stores or anyone else who wants to purchase my books, needs to pay for them in a timely manner just as they would to a l

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

rge publishing house. When you sign a contract with any distributor or bookseller, make sure you are happy with the terms. Be sure to pay close attention to how your payments start coming in, if

.

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

they are on time and in full or late and have deductions or errors. The sooner you correct anything that is not correct the better. Don’t just accept 120 day terms from someone because, that is th

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

Companies that provide selfless information through particip

ir standard. You can accept their terms or tell them yours and be in control. You can certainly meet them halfway, but if receiving your money late is going to cause you to lose money, don’t do it

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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As an immigrant myself, I understand the hopes, fears, dreams and unique problems faced by immigrants, no matter where they are in the world. Having worked with hundreds of immigrants, I know how hard it is to start all over again. Here is one way that never fails to turn things around.

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