Alliance Institute of Advanced Pharmaceutical & Health Sciences Skill India NSDC PMKVY LSSSDC
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  Drug Development & Regulatory Affairs
Alliance Institute of Advanced Pharmaceutical & Health Sciences
Alliance Institute of Advanced Pharmaceutical and Health Sciences is offering most important and Industry oriented program in MS Drug Development and Regulatory Affairs. This program is useful for B.Pharm and M.Pharm students who are interested in taking up carrier in Regulatory Affairs.

Traditionally, most regulatory affairs professionals entered the discipline from other areas, such as clinical laboratory or clinical research. Often people were just thrown into the deep end by giving them a pile of regulations, and with luck they worked with a good mentor who was willing to share the skills that they had learned when once placed in the same nerve-racking position

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MS in Industrial Pharmaceutics
Now, thankfully, things have changed with the advent of degree courses that can provide such training. A small number of postgraduate degree courses related to regulatory affairs have been set up worldwide, In India Alliance Institute teamed up with Jawaharlal Nehru technological University, Hyderabad to offer this program which outline the Drug Development Process and how this is regulated

Pharmaceutical industry is well known as being one of the most highly regulated, revolving around the approval of new compounds that emerge from the drug development pipeline by national or International regulatory bodies

Once a Industry identifies a promising chemical entity, a regulatory-affairs team begins drawing up the plan that will guide the compound through development, clinical trials and onto the pharmacy shelves.

Most of the agencies provide guidance on how a new drug should be tested, but it's not always black and white. Interpretation makes regulatory affairs interesting and intellectually challenging so Alliance has taken up challenge to train student to produce topnotch regulatory professionals.

Most pharmaceutical companies have an individual department for handling regulatory affairs; those that do not have this facility use external service providers, such as regulatory consultancies or contract research organizations that provide regulatory services
Who Should consider a career in Drug Development and Regulatory Affairs?
bullet If you are interested in working in  a business sector that can influence the health and well-being of billions of people.
bullet If you want toconstantly extend your scientific and legal knowledge.
bullet If you want to work with intelligent, driven colleagues on projects that challenge your thinking and allow you to stretch yourself.
bullet To exercise personal skills in a role that has exciting career opportunities to the highest level.
How do I get into the profession?
Alliance Institute gives training for qualified B.Pharm or M.Pharm students and young professionals to take up challenge in regulatory affair. Alliance prepare practice ready professionals in regulatory area:
bullet Alliance strive to train and  demonstrate that student  have some of the technical and personal skills needed by a good regulatory person. The ability to deal with a range of scientific disciplines, negotiation skills, team-working skills, the ability to work under pressure to an agreed deadline, good verbal communication and the ability to write clearly and summarise data effectively are all important.
bullet Alliance provide training to become familiar with current regulatory issues. Knowledge of the basic regulatory processes can be gained from textbooks which should be held in the pharmacy section of your library.

What is Drug Development and Regulatory Affairs?
Drug Development and Regulatory Affairs is a comparatively new profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.

The companies responsible for the discovery, testing, manufacture and marketing of these products also want to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare. Most companies, whether they are major multinational pharmaceutical corporations or small, innovative biotechnology companies, have specialist departments of Regulatory Affairs professionals – and those who don’t, rely on the expert advice of independent regulatory consultants to meet their obligations.

The Regulatory Affairs professional’s job is to keep track of the ever-changing legislation in all the regions in which the company wishes to distribute its products. They also advise on the legal and scientific restraints and requirements, and collect, collate, and evaluate the scientific data that their research and development colleagues are generating.

Regulatory Affairs professional’s are responsible for the presentation of registration documents to regulatory agencies, and carry out all the subsequent negotiations necessary to obtain and maintain marketing authorisation for the products concerned.

Regulatory Affairs professional’s give strategic and technical advice at the highest level in their companies, right from the beginning of the development of a product, making an important contribution both commercially and scientifically to the success of a development programme and the company as a whole.

It may take anything up to 15 years to develop and launch a new pharmaceutical product and many problems may arise in the process of scientific development and because of a changing regulatory environment. Regulatory Affairs professionals help the company avoid problems caused by badly kept records, inappropriate scientific thinking or poor presentation of data. In most product areas where regulatory requirements are imposed, restrictions are also placed upon the claims which can be made for the product on labeling or in advertising.

The Regulatory Affairs department will take part in the development of the product marketing concepts and is usually required to approve packaging and advertising before it is used commercially. Many companies operating in the high-technology health-care and related industries operate on a multinational basis and are very significant exporters.Their Regulatory Affairs departments must be aware of the regulatory requirements in all the company’s export markets.

As an added complication, despite recent international efforts towards harmonisation of requirements, the regulations laid down by different governments and their interpretation by the regulatory agencies, rarely match. Consequently, the registration data prepared for one country frequently fail to meet the requirements for another.Therefore great care has to be taken in drawing up efficient and economical research and development programmes whose results may be used as widely as possible. Regulatory Affairs professionals

Why is Regulatory Affairs important in Pharmaceutical and biotechnological Industry?
In today’s competitive environment the reduction of the time taken to reach the market is critical to a product’s and hence the company’s success.The proper conduct of its Regulatory Affairs activities is therefore of considerable economic importance for the pharma company.

Inadequate reporting of data may prevent a timely positive evaluation of a marketing application. A new drug may have cost many millions of pounds, Euros or dollars to develop and even a three-month delay in bringing it to the market has considerable financial considerations. Even worse, failures to fully report all the available data, or the release of product bearing incorrect labeling, may easily result in the need for a product recall. Either occurrence may lead to the loss of several millions of units of sales, not to mention the resulting reduction in confidence of the investors, health professionals and patients.

A good Regulatory Affairs professional will have a ‘right first time’ approach and will play a very important part in coordinating scientific endeavour with regulatory demands throughout the life of the product, helping to maximise the cost-effective use of the company’s resources.

As a Regulatory Affairs Professional progresses in his/her career, aspects of project management and strategic planning become more important. Individuals need to develop the ability to anticipate problems, analyse complex situations, and offer the optimal strategy in order to achieve marketing approvals worldwide in a timely manner


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