Monday 5 October 2015

Excellence in regulatory documentation rendered by medical writer

Regulatory Medical writing is an activity of writing scientific documents which are pivotal for the approval of any new drug or device. A team of specialized medical writers are involved in the preparation of Investigational Medicinal Product Dossier (IMPD), Clinical Trial Application (CTA), Common Technical Document (CTD), Investigational New Drug (IND) & New Drug Application (NDA). The regulatory medical writers must have the good knowledge of new and changing global regulations and ICH guidelines to meet the requirement of sponsor. At WorkSureTM we have the capability to work for regulatory framework of various countries including USA, Canada, Europe, Japan, India etc.

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Industries are helping medical research and communication activities

Newer treatments and bettering healthcare services are increasing life expectancy with improved quality of life. Various pharmaceutical, biotech industries and medical service KPOs are stepping forward to facilitate delivery of evidence based health care to the patients. WorkSure™, a growing name in healthcare KPO, has taken FMRC (Facilitated Medical Research Communication) initiative to help bridge the gap and increase India's share in biomedical research. This unique program is specially designed for assisting the Healthcare Fraternity to promote medical research at the level of hospitals, clinics as well as individual physician. WorkSure™ also promotes public private partnership in medical research and drug development.

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