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Building a new home, renovating an existing house, or doing home improvements to properties, involves considerable planning and has large financial implicati

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

ons to all involved. It is therefore extremely important to appoint a contractor who has the necessary background, expertise and a good track record.

When l

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

Examples of combination products may in

ooking for a contractor you may want to consider the following suggestions:

1. Do not accept the lowest tender just because of the price!

- Ask at least th

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

ree (3) contractors to quote on the work you want done.
- Stipulate what detail you want specified in the tender and compare the tenders to ensure that

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

the contractors have priced all items and then evaluate the tenders.
- Compare all prices against each other to evaluate why one tender is cheaper than

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

Combination pro

he other.
- Request the contractor to specify in his tender, in detail, what materials are to be used and where, in order to avoid disputes later.

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

- Contractors may price some items provisionally in order for you to choose from other related products, or if they are unsure of the quantities.
- 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 that tenders allow for the same provisional quantities and products.
- Carefully examine the tender, and award the tender based on specifications,

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

not only on the price.

2. Read the contract

- Read the contract and make sure of your obligations before signing it.
- Be careful for biased wording

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

in the contract.
- Do not sign any documentation until you formally award the tender to a specific contractor.
- The contract must be properly unde

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

stood and signed by both parties.

3. Check the contractors references before awarding the tender

- Ask for references and follow them up by phone, or go an

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

Following aspects would a

d see the work that was previously carried out.
- Check whether the quality suits you and find out how the contractor treated his clients before signin

dd to the challenges in developing combination products:

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

g, also ask them of the after sales service they received, if any was needed.

4. Do not pay deposits without security

- It is common for contractors to req

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

uest large deposits up front.

5. Do not pay whenever the contractor request payment

- Payments should be scheduled in the contract and paid accordingly, on

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

receipt of a invoice. Keep record of all payments.

6. Keep records and do not negotiate in good faith without documentation.

- A full written record of al

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

decisions taken between yourself and the contractor should be kept. Dates and pricing (where applicable) should always be mentioned.
- It is normal for

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

Professional from academic institutions, pharmaceutical industries, health care indust

decisions to be taken during the contract to change original specifications.
- Before the contractor implements any changes, make sure he has given a p

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

rice (additional cost or saving) for the change, and be sure that you keep records of all the additional costs, as these extras can mount up in value and inf

.

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

luence your budget.

7. Do not accept poor workmanship

- If you are unhappy with any aspect or quality of any portion of the work, inform the contractor as

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

Companies that provide selfless information through particip

soon as possible as certain aspects may be difficult or impossible to rectify later.
- Insist that mistakes are rectified before final payments are made

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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