Ahmedabad

Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of 23,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics — ensuring a higher level of healthcare for people.

The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in India have major focus areas of human health that include: cardiac management, cardiology, diabetolology and neuropsychiatry.

About Authors:
S Hamza*¹, Dr Tanveer Aalam², Dr Asma^3
1*  Assistant Professor, Department of Pharmacology,
Shree M V Shah Pharmacy college,
Gajan, Modasa: 383315, Gujarat.
² Department of Emergency Medicine,
Apollo hospitals International Ltd,
Bhat GIDC estate,  Gandhinagar: 382428, Gujarat.
³ Medical Officer, Civil Hospital,
Ahmadabad: 380 002. Gujarat, India

ABSTRACT:
India suffers from the highest number of deaths - around 1,05,000 in absolute terms annually- due to road accidents in the world owing to poor infrastructure and dangerous driving habits according to the World Health Organisation¹. Calling road fatalities an "epidemic" that will become the world's fifth biggest killer by 2030². It is said that 90% of deaths on the world's roads occur in low and middle-income countries (21.5 and 19.5 per lakh of population, respectively) though they have just 48% of all registered vehicles.

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Lupin Limited is an innovation led transnational pharmaceutical company producing a wide range of quality, affordable generic and branded formulations and APIs for the developed and developing markets of the world. The Company today has significant market share in key markets in the Cardiovascular, Diabctology, Asthma, Pediatrics, CNS, GI, Anti-Infectives and NSAIDs therapy segments, not to mention global leadership positions in the Anti-TB and Cephalosporins segments.

NEXTUS SOLUTIONS is a professionally managed organization engaged in offering highly acclaimed consulting, Training and Placement. With our in- depth expertise and rich experience in the field of domestic as well as international level, we have been serving aspiring candidatesand organizations in the most professional way.

Famy care is a global player in the Female Health Care Segment with a focus on Hormonal & Reproductive Health Care Products. Famy care believes in the right of women to be informed about their reproductive healthcare choices and to make good health accessible to all. In a very short span of time we have become the largest manufacturer of Hormonal Tablets.

NEXTUS SOLUTIONS is a professionally managed organization engaged in offering highly acclaimed consulting, Training and Placement. With our in- depth expertise and rich experience in the field of domestic as well as international level, we have been serving aspiring candidatesand organizations in the most professional way.

Roselabs ltd., is a group companies established in 1995. Its always been working with the vision of having BETTER TOMORROW. Recently it entered the area of providing life saving drug's and a lot more pharmaceutical formulations with best quality. We specializes in gynecologic and cardiac range of medicines. Our manufacturing plants to labs and infrastructure are totally accredited as well as are most advanced for the best quality.

About Authors:
Dolita Shah^*, Mayur Mistry^1
*M.Pharm (Q.A, Gold Medalist),
Asst. Professor, Smt. R. B. Patel Mahila Pharmacy College
¹Production officer, Intas Pharmaceutical ltd,
Ahmedabad, India

Introduction
A new molecule can cost several millions of rupees or dollars to progress and any blunder causes greater impact on company’s status. As medicines play a vital role in human’s life there must be regulations for medicines ensuring Quality, Safety and Efficacy of drugs. The regulatory affairs professional is the only one who is completely responsible for holding products in compliance and maintaining all the records. One of the vital activities of the regulatory specialist is to ensure that the all the information regarding medicines has been correctly established to the patient covering labelling also. Even a small mistake in any of the activities related to regulatory can make the product to be recall in addition to loss of several millions of the money.