DRA

PAREXEL International is a growing, fast-paced, global Clinical Research Organization (CRO) that has helped bring to market 49 of the top 50 selling pharmaceuticals. In fact, we have worked with all 10 of the world's top 10 pharmaceutical companies.

20 years Old Bulk Drug Manufacturing company having 3 production facility around chennai.More than 250 employees. USFDA/EDQM Approved, Supllier to almost all major Pharma companies throught the world.Poised for Rapid Growth to become 500 CR + company

Post: Executive - Regulatory Affairs

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Neon was on preparation for Indian Market that the company first concentrated. However, it was only a few years later we began manufacturing to order medicines for Pharmaceutical company. Finally, in 1985 NEON entered into ethical marketing having wide set up of marketing team.
Today, NEON is looked up to as the sign of Radiating Health Care, with a spectrum of products that have earned the confidence of millions.

CliniExperts is a joint effort of Clinical Research professionals who have a wealth of knowledge in various aspects of the Clinical Research Industry. Provides services in Indian Pharma regulatory affairs, Clinical Trial Management , BA/BE Studies , Audit and Training.

Post: Regulatory Affairs Trainee - 1 post

Abbott India Limited is a subsidiary of Abbott Laboratories, USA, a global, iversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company now employs approximately 70,000 people and markets its products in 130 countries worldwide.

Head office of “Ananta Medicare Ltd” is situated in the centre of London, in business district Fulham, United Kingdom. The company specializes in manufacturing, marketing and distribution of medicinal products of high quality at affordable process for all categories of customers in pharmaceutical markets of Europe and Asia.

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.

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.