Advice You - Business

You have decided to outsource your business. Which path are you planning to take? Some firms catch the progressive path by taking the help

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

of outsourced stalwarts, who have a hold on things, and later, switch to their own path of outsourcing.

It is better to check all the pr

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

Examples of combination products may in

s and cons and then come to a decision.

Your first step should be to catch someone who serves as your mentor. If you do not wish to colla

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

orate with consultancies, then take the help of interim management service. In short, you should have someone, who is well versed with the

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

entire scenario of outsourcing, is familiar with the risks and market trends, and knows how to handle them.

Once you have picked your “Go

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

Combination pro

d Father”, you should provide them with clear-cut references. After that, work towards building a diligent outsourcing team. Do not ignore

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

building a team, as this is inevitable.

Sit and discuss all the issues with your team, including optimizing the process, the costs involv

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

d, handling disasters, and setting targets. You have to be clear as to what you want to achieve and how. Chart out a performance chart and

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

what you expect from your employees.

Important aspects of outsourcing are: service level agreements (SLA).

What Is Service Level Agreeme

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

nt (SLA)? The SLA is a legal bond between your company and the outsourcing vendor. It is a document that elaborates your services and its

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

levels in a precise manner, along with the details of the agreement, and its terms and conditions.

SLA is divided into two parts: The reg

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

Following aspects would a

lating part and the process part. The latter includes the processes that the outsourcing vendor is going to utilize as a support for the a

dd to the challenges in developing combination products:

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

reement. However, you should thoroughly discuss all the processes that the vendor is going to use before finalizing the agreement. The ven

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

dor has the privilege to pick the processes. It is essential that you and the vendor should come to an agreement on all the processes.

Th

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

Significance of SLA: SLA represents a major chunk of the entire solution. Your vendor and you have to decide the perfect people for the

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

ob, the ones who have the “substance” to manage the processes as well as the technologies. They should be accountable enough to report and

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

Professional from academic institutions, pharmaceutical industries, health care indust

evaluate the whole process.

Why Is SLA Prepared? The concept of SLA was invented with an aim to accurately determine the support require

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

ments for a firm regarding the outsourcing infrastructure.

SLA cannot be formulated by the outsourcing company alone. The outsourcing ven

.

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

ors have to intervene with their experience and management expertise to provide valuable guidance and information.

At the end, it all dep

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

Companies that provide selfless information through particip

nds on the judgment of both the parties with regards to collecting the information from proper sources and selecting the best of the ideas

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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