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Every person seeking a home loan has to follow certain steps from start to settlement. Understanding each step and how it works prepares you for the process and can, hopefully, get you into your new home faster.

Preparation
• K

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

now your finances and budget inside-out, and prepare a list of your assets.
• Do some initial research about home loans and mortgages.
• Get some background information on the company or person you’re approaching or a refer

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

Examples of combination products may in

ral from a previous customer.

Initial contact
• Get additional information about the mortgage provider.
• Find out the names of the lenders on the broker’s panel — the lenders the broker deals with — or what loan products

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

a lender offers.
• Advise how much money you are seeking to borrow, outline your finances and personal details.
• Organise a time and place (preferably their office) to meet.
• Determine what documents you need to brin

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

g to the meeting.

The more information you can provide the mortgage provider in this step the more prepared they are for your meeting.

The meeting

There are usually five stages of the interview:

Introduction: will cover what will

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

Combination pro

happen in the interview, information about the company you’re dealing with (their panel of lenders if they’re a broker, or their products if a lender) plus their commissions and fees.
Qualification: provision of documents to su

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

pport your financial situation and budget; discussion about the size of the loan you require and its use; such as for an investment or principal place of residence.
Offer: discussion of loan products, matching you to a loan prod

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

uct/s, if using a lender a discussion about the types of loan products. Other mortgage providers will also discuss products and compare the different loan products from their panel of lenders. Use of calculators to determine repaymen

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

ts and upfront and ongoing fees. Deciding what loan/s to apply for.
Application: signing a finance broker contract and privacy declaration form (agreeing to what you and the broker discussed, allowing them to provide information

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

to third parties). Completing the application form, and declaring the information provided is correct.
Close: advises what happens next, and up to settlement, expected time frame for the next contact, and returning original doc

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

ments and your copy of the Finance Broker Contract.

The application
Your mortgage provider will:
• Review the application, check details and complete any missing information.
• Attach supporting documents.
• Comp

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

Following aspects would a

lete a serviceability sheet — to demonstrate your ability to pay back the loan.
• Send on to the assessor.

The lender’s assessor will:
• Log the application, allocate a file number to it and confirm receipt of application.

dd to the challenges in developing combination products:

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

• Check it is completed correctly and has all relevant documents (or return it if incomplete).
• Undertake detailed review and complete relevant checks.
• Log all the information on to your file.
• Pass the file

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

to the team leader with a recommendation to approve or decline the loan. If approved by the lender a pre-approval or conditional approval is sent back to the mortgage provider to inform the borrower.

Pre-approval or conditional app

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

roval
Advises that your loan is approved subject to certain conditions, such as finding a property. The conditional approval usually lasts for about three months and should not cost you anything.

Valuation
The lender will

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

conduct a valuation on the property you have chosen to show its market value and ensure they are lending within their guidelines.

Unconditional approval
Granted when all the conditions of the loan have been met, and all costs a

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

Professional from academic institutions, pharmaceutical industries, health care indust

re determined, such as establishment fees, stamp duty, and lender’s and solicitor’s fees.

Letter of offer
This document delineates the terms, conditions and costs of the loan. Get your solicitor to review the letter of offer an

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

d, if OK, sign it and send it back to the lender so their solicitors can proceed to settlement. Once signed, it becomes the credit contract.

Mortgage documents
Sent with the letter of offer, they outline the agreement between t

.

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

he lender, borrower and the Office of State Revenue. The details of the mortgage are recorded on the Certificate of Title along with the name of the borrower/owner and the mortgage lender. This process will be managed between the len

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

Companies that provide selfless information through particip

der and your solicitor.

Settlement
Settlement occurs when the loan funds are drawn down to pay for the remainder of the property and the relevant costs. The date of settlement will be managed between the lender and your lawyers

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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