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A consulting engineer are called by client when client does not has engineering capability, his engineering staff not qualified in work area, client cannot free his engi

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

neering staff from present commitments, or client needs an outside objective analysis (Refer to article Reason for engaging civil and structural engineers).

Normally the work of civil and struc

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

Examples of combination products may in

ural consulting engineer starts when then engineer signs a contract with client. Frequently, the employment of civil and structural consulting engineer will continue whenever the first task for

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

client has been fully satisfied. In a design office such as civil and structural consultant, there are a number of work needs to be done as follow:

1.Feasibility studies. When client has a gen

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

ral idea of what he wants on a specific assignment, he may be uncertain about the scope of work. Consulting engineer is called and carry out studies and reports in variety of way. Based on the r

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

Combination pro

eports forwarded to client, client is able to determine the workability of his assignment

2.Preliminary design. After a project is awarded to engineer, initially client may want to know some p

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

eliminary information such as initial cost estimation, equipments, local authorities’ requirements etc. Consulting engineer plays an important role in this matter. In this stage, it may start wi

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

th some submission of works to authorities for approval.

3.Liaise with client, architect, quantity surveyors, mechanical and electrical engineers and local authorities. In order to accomplish

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

he project, civil and structural consulting engineer has to all the time liaise with client and update the changes of client. During the preparation of the preliminary design, civil and structur

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

al engineer needs to liaise to architect, quantity surveyors, mechanical and electrical engineers and local authorities. He has to incorporate the entire requirement from these parties into his

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

esign.

4.Detailed design. Further to the requirement obtained, he is able to prepare detail design such as actual building structural, drainage system, water supply and sewer system for the pr

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

Following aspects would a

oject.

5.Preparation of drawings. All these details are further transform into drawings.

6.Cost estimation. When details design drawings is ready, consulting engineer may require preparing c

dd to the challenges in developing combination products:

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

st estimation for client. If client has in house quantities surveyors, he will carry out his own cost estimation and compare with consulting engineer results. Budget will be checked.

7.Preparat

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

ion of tender document. When all the requirements and needs have satisfied the client, it wills be the time for preparing tender document. Tendering will be called.

8.Evaluation of tender.

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

fter tender closed, reports for evaluation of tender will be forwarded to client. In the reports, engineer will propose recommendation to client. Client will based on his best judgment and selec

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

t a candidate.

9.Getting approval from authorities. During preliminary design until tendering or even during construction, consulting engineer needs to liaise with authorities for getting all

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

Professional from academic institutions, pharmaceutical industries, health care indust

ecessary approval from local authorities. Without the approval from authorities, project cannot be accomplished.

10.Project supervision. After the awarded of project to candidate, projec

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

t will commence. This is the time of supervision of project start. Throughout the project, quality control must be given the highest priority. Civil and structural consulting engineer will base

.

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

n his best ability to monitor the project. Attention to quality control during the design and bidding stages will be wasted if adequate of inspection by the consulting engineer is not carried ou

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

Companies that provide selfless information through particip

t during construction.

Civil and structural consulting engineer is all the time facing with items that mention above. He will be based on his own professionalism to overcome the mention matters

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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