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E-Folder - Corporate Records - What to Keep
Whether you’ve created a corporation or limited liability company, you must maintain records. Here’s a primer on the basic corporate records you need
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
to maintain.
Corporate Records
When forming a corporation or limited liability company, you are creating an entity independent from yourself. In so
Corporate Records
When forming a corporation or limited liability company, you are creating an entity independent from yourself. In so
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
doing, this independent entity must take actions for itself, not you. For instance, a corporation will have a corporate bank account through which all
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
revenues and debt payments are handled. As a shareholder, even with a single shareholder entity, you will not pay person expenses out of the corporat
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
bank account. This concept extends to record keeping.
For the purpose of this article, I am considering both corporation and limited liability compa
For the purpose of this article, I am considering both corporation and limited liability compa
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ny documents as “corporate records.” Although the records of each entity have different names, they serve the same purpose. For instance, articles 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
incorporation for a corporation serve the same purpose as Articles of Organization. The following list applies to corporations, but you can apply the
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
list to the limited liability equivalents.
Although each state has different records requirements, all require you to keep the following records.
1.
Although each state has different records requirements, all require you to keep the following records.
1.
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
Articles of Incorporation – The charter establishing the existence of the entity with the relevant Secretary of State.
2. Bylaws – The rules of the c
2. Bylaws – The rules of the c
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
orporation. Essentially, the bylaws set out how the corporation will be administered from a procedural perspective, the rights of shareholders, how me
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
etings will be called and so on.
3. Board Resolutions – These are resolutions passed by the Board of Directors from time to time, such as defining cl
3. Board Resolutions – These are resolutions passed by the Board of Directors from time to time, such as defining cl
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
asses of corporate stock and approving particular courses of action for the business.
4. Minutes of Shareholder Meetings
5. Annual Meeting – Every s
4. Minutes of Shareholder Meetings
5. Annual Meeting – Every s
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ate requires a corporation to have at least one meeting of the board of directors each year. Keep these in your corporate book.
6. Shareholder Commun
6. Shareholder Commun
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ications – Copies of all communications to shareholders. Most states require you to hold these for three years, but you should keep these permanently
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
to guard against future shareholder lawsuits.
7. Shareholders – A list of shareholders and the shares they own.
8. Annual Report – Most states requi
7. Shareholders – A list of shareholders and the shares they own.
8. Annual Report – Most states requi
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
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
re you to file an annual or bi-annual report with the Secretary of State. Keep copies of these in your corporate records. Most states provide a pre-pr
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
nted form.
9. Balance Sheets – Shareholders have the right to inspect the finances of the corporation, although this right has limitations. You need
9. Balance Sheets – Shareholders have the right to inspect the finances of the corporation, although this right has limitations. You need
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
to keep up to date balance sheets.
10. Tax Returns
So, how long should you keep these corporate records? Some attorneys will tell you three or five
10. Tax Returns
So, how long should you keep these corporate records? Some attorneys will tell you three or five
.
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
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
years. Personally, I believe you should keep them permanently. If a shareholder dispute occurs, you don’t want to testify you through away a document.
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
If the business is eventually sold, the buyer is going to want to see all corporate records. Either way, you are better off holding on to all records
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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