Advice Pool - Finance

We see web sites out there offering offshore services like assisting with bank account openings that offer to be the signer on the account for the customer. This frequently results

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

in trouble for the customer. Let us discuss this in detail.

First off these people have no idea what you or any other customer is doing with the bank account. They risk being com

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

Examples of combination products may in

plicit in any illegal activities the person may be involved in and thus drawn into investigations, being served with subpoenas, notices of deposition, being arrested and other cour

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

orders. So if one of their clients is a bad guy all their records for all their clients including you will come under disclosure and scrutiny. No attorney client privilege or bank

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

secrecy to shelter you and your privacy. Not good.

Attorney Client Privilege is a big missing piece of the asset protection structure. These people are not lawyers. They can not

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

Combination pro

ffer you privileged communication. The signatory is often free to do whatever he or she wants with the information they have about you and your affairs. It is also easy to obtain r

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

ecords from them by court order since there is no attorney client privilege being violated. Remember the signatory must have and keep records showing who is in fact ordering him to

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

disburse funds. This is to protect himself from being prosecuted for embezzlement. This also means the signatory is going to have a copy of your passport and other ID plus a contra

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

ct executed by you appointing them with details as to how things are going to be executed. Not so good either.

Bank Secrecy is also missing even though you may be using a bank in

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

country like Panama where there is bank secrecy. You have no dealings with the bank, only the signatory does so the bank secrecy does not protect you.

Embezzlement is another pro

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

blem. What if the signatory arranges for the online bank access to be obtained by someone who depletes the account by wiring funds to Vietnam or Nigeria and then the signatory clai

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

Following aspects would a

ms he has no idea what happened. Maybe he got hacked. There is no trail to him so what are you going to do? This is not the time to be going back and reading the agreement you sign

dd to the challenges in developing combination products:

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

d with them for the first time. You’ll find they have no liability unless you can prove they were the thief. You are not dealing with a lawyer, you are dealing with a broker of cor

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

porations located in some offshore island jurisdiction. Want to go there and sue them? Think you’ll win when you signed their documents?

As a safe alternative read this section on

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

protectors of Panama Foundations.

It is a way to protect your money without being the signatory on the account. There is a way to make the bank the trustee of the account and as 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

rustee they can be the signatory. You can still be the protector and thus need to approve all outgoing transactions, without your approval nothing leaves the foundation bank accoun

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

Professional from academic institutions, pharmaceutical industries, health care indust

. You are the protector not the signatory. Having the bank as the trustee and being the signatory is not exactly the same as using some corporation reseller located on some offshor

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

e island. There would be bank secrecy to protect the structuring of the account. Anything your attorney did would be privileged communication. The bank would need to understand the

.

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

nature of your business, they would be on guard for money laundering, ask questions about bank account activity, suspicious wires to risky countries like north Korea for instance,

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

Companies that provide selfless information through particip

they would know exactly who you are, etc. But everything would be protected from disclosure and you are dealing with a Panama licensed financial institution. Does this sound better

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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