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Understand the handling of the business before contemplating outsourcing it offshore. Determine what facet of the business you want to outsource, why you

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

want to do so, who will handle the offshore project and the time frame for its completion. Contact the outsourcing business company to do the necessary th

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

Examples of combination products may in

ngs.

Tips for outsourcing:

1. Define the current process. It allows you to understand the requirements and details of what actually needs to be done. It

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

should be non-ambiguous and offer a measurement method. Information of specific customer queries and time required is of great help while transferring tha

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

process over to your new outsourcing partner.

2. Do a cost analysis of the proposed process. Have a realistic and solid estimate of the current operati

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

Combination pro

ng costs of the process under consideration for outsourcing. Consider all the costs involved, even the marginalized expenditure to have a clear picture. T

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

e in-house calls can be answered within a certain time because of available support, but on transfer it can take longer both in time and in cost. Consider

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

the costs honestly to work out the beneficial cost saving for the business.

3. Manage the relationship. Make efforts to establish a good relationship. H

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

ve a clear understanding of transfer terms. Communication channels should always be open with a flexible attitude. A liaison officer should take responsib

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

ility to address staff concerns of their jobs. He should keep the staff informed and have an effective and regular dialogue within the company. Transfer o

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

employees should conform to employment legislation. A flexible contract benefiting both parties can be drafted. It allows you to innovate to changing cir

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

Following aspects would a

umstances and renegotiate the contract before the term ends for the employee’s benefit.

4. Aim for smooth transition. Even with good planning, a lot of

dd to the challenges in developing combination products:

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

imes the transition or migration of an employee can cause many problems. It can be litigator in nature or lead to severance of a good employee. Since it’s

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

a learning curve for both the parties, use this opportunity to modify the service level agreement (SLA) for the future.

5. Measure success. Quantify an

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

measure the benefits your company accrues for outsourcing. The foremost is the financial benefit for the company. It could also lead to notching higher p

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

ofile and credibility for your company. Outsourcing means fewer defects in your work and greater speed for work completion in optimum cost and time frame.

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

Professional from academic institutions, pharmaceutical industries, health care indust

6. Plan a clear exit strategy. Have a clear exit term integrated in your service level agreement (SLA). Clarify who owns what and how much percentage of

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

both movable/immovable assets. Specify the compensation or severance due in case of end of partnership. This clause is very important for amicable dissol

.

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

tion of collaboration if the relationship ends prematurely or simply runs its course.

Off shoring a part of your business makes sound economic sense, as

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

Companies that provide selfless information through particip

t can lead to substantially reduced operating costs. A clear understanding of the outsourced work will avoid many a pitfall later and yield better results

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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