March 2012

Regulatory writing is a highly scientific niche that involves the production of documentation required for the approval of drugs by regulatory authorities. The documents are created based on specific templates and guidelines that report the results of clinical trials and are ultimately submitted to the US Food and Drug Administration (FDA). Other national agencies include Health Canada (Canada), European Medicines Agency (EMA) (European Union), and the Ministry of Health, Labour and Welfare (Japan).

Publication writing essentially means tailoring of clinical and scientific data and information for publication in public domain targeting specific audience. This involves development of articles for publication in a journal, an abstract or poster for presentation in symposium/conference.

National Institute for Research in Reproductive Health (NIRRH), formerly known as Institute for Research in Reproduction is a premier research institute of the Indian Council of Medical Research (ICMR). It is situated in the vicinity of a number of hospitals and research institutes in central Mumbai. Since its inception in 1970, it has been making vigorous efforts to improve the reproductive health of people through research, education and health care services.

Gandhi Institute of  Technology and Management,  popularly known as GITAM was founded in 1980 by an inspired group of eminent intellectuals and industrialists of Andhra Pradesh led by Dr. M.V.V.S.Murthi, Former Member  of  Parliament  and popular philanthropist.   Their mission was to set up a  world-class technology &nbsp

Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health.  We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals.

About Authors:
Nilesh Sovasia, Prof.Sanjeev Thacker, Tarun Patel
Seth G.L.Bihani S.D.College Of Technical Education,
Institute Of Pharmaceutical Science & Drug Research,
Sri Ganganagar,
Rajasthan, India

ABSTRACT
Despite a company's best efforts to design, manufacture and sell safe and reliable products, the possibility still exists that dangerously defective products may reach the customers. These products may cause accidents,leading to adverse verdicts in product liability litigations.There for Quality management of Complaints and Product recalls are essential to ensure the safety of customer.