Main Subject - Business

It is a common trait in today’s fast paced market that organisational growth can happen in rapid, large bursts. Being able to effectively manage your business during times of crucial development plays a very important role in shaping your future prospects. Human Resources, by the very nature of the phrase itself, is one of the most integral parts of whic

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

h a business or organisation is made up. In times of growth, both large and small enterprises need to be able to focus on their business strategies rather than being hampered down with issues on how to develop and maintain a supporting infrastructure for such growth.

In cases where your entrepreneurial endeavour was once a solo act, you might suddenly f

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

Examples of combination products may in

nd yourself in the situation where you have to hire additional staff members to help manage your workload. Having to deal with this new growth and the added pressure of HR engagements can prove to be unnecessarily time consuming.

In medium to large enterprises, where human resources tend to become decentralised, a restructuring and upgrading of HR manag

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

ment might prove to be beneficial to the streamlined growth of the company.

It is in cases such as these that the option of outsourcing Human Resource management becomes a viable, if not necessary option to the effective and healthy development of a company. There are various factors to consider when choosing the most suited consultants to outsource you

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

HR management to. In order to identify the most suited match for your business, you firstly need to identify which field of expertise you require. This will be determined by the type of organisation, workplace flexibility, the role of the organisation in society and workforce development.

If your organisation is based upon the manufacturing sector, you

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

Combination pro

HR requirements will be geared towards employee welfare, management of unions, industrial relations, management of disputes at the conciliation level and labour court level and long term career and succession planning. You need to find a consultant who is experienced and specialised in these areas.

If your organisation is grounded in the IT or financia

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

sectors, you will require a consultant who is more experienced in HR management areas such as fast track training, managing a fluid workforce engaged a high performance environment, fixed-term employment, short-term as well as long term career planning, innovative performance management, compensation and benefits plans.

It is generally said that in the

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

manufacturing sector, HR predominantly involves a more employee based role right from recruitment until retirement, whereas in the IT/financial sector, the role of HR involves more creative planning for the implementation of strategic practices. It is therefore essential to choose a consultant who is knowledgeable in your specific requirements.

Some of

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

he services which you might require from HR consultants at workforce level include education, training, motivation and data management. At managerial level, consultants are able to offer such services as enhancements in policies and procedures, organisational change, managerial effectiveness and legal compliance.

HR consultants should generally offer va

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

ious methods of training to their clients from junior operative to senior management levels. Such training can be presented as both interactive classroom sessions or regular bulletin updates delivered via newsletter or online media e.g. email. What method of training you choose will depend on the accessibility and size of your organisation.

Employee mot

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

vation is of great importance to an organisation operating in a high pressure environment. HR consultants will help you generate constructive assessments in employee effectiveness, as well as surveys dealing with employee satisfaction. Identifying such issues will help to accurately resolve them, thus driving the effectiveness of your company.

A streaml

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

Following aspects would a

ined data management system benefits the functionality of an organisation in that it enables you to manage data and processes impacting job application and interview monitoring, equal pay gap analysis and performance measures. Furthermore data management assists in the understanding of data privacy requirements on individual access rights and record rete

dd to the challenges in developing combination products:

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

tion which may include writing policies to support business requirements and legal compliance, as well as setting up systems to protect your data. This makes up an integral part of human resource management, and should not be overlooked when outsourcing these services.

It is a reality that there are certain policies and procedures that need to be follow

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

d in order to better serve both you and your employees. An effectively implemented HR management system will allow for the provision of basic policies to ensure that you meet the legal minimum requirements. A consultant will also be able to assist in the design of new policies, employee handbooks and process guides to bring everybody in the organisation

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

o a level of understanding as far as procedural matters are concerned. In light of this, having outsourced your HR management to a consultant, you should be kept up to date and fully briefed on any new changes in legislation. The HR consultant should work to ensure that all your policies, procedures and employee interventions are in keeping with best pra

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

tice and legal requirements, and assist in the design and implementation of new or revised policies and procedures to best comply with changes in the law.

In today’s ever changing marketplace, organisational change is an unavoidable part of any forward moving enterprise. It is human nature to avoid change, and therefore facilitating the process within y

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

Professional from academic institutions, pharmaceutical industries, health care indust

ur organisation can greatly benefit you and your employees on the road forward. HR consultants are able to use a range of solutions to ensure that any organisational change, including redundancies and reengineering of processes, is managed effectively in line with good practice as well as ensuring that the welfare of your employees and business is not ad

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

ersely affected by the change.

A great driving force behind the success of organisational change is managerial effectiveness. An HR consultant will be able to provide training and coaching to enable leaders to handle difficult issues such as disciplinaries, grievances and dispute resolution. Furthermore, a consultant should provide effective methods in

.

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

ealing with organisational change, whilst keeping employees supported and motivated. Effective management stems from having a clear perception of your company’s vision and goals, and therefore the design and implementation of effective performance management programs that are directly linked to these goals should be of high priority to anybody entering i

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

Companies that provide selfless information through particip

to an outsourced HR system.

You can gain a very comprehensive idea of what a consultant agency has to offer by researching their web page and/or contacting them to request a hardcopy brochure. It is also a good idea to research the type of clients they currently support in order to determine if they will be able to provide you with the services required

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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