Wednesday 25 March 2015

Operating a medical information function to field product queries.



Medical Affairs play an important function which is required for development and commercialization of medicines between patients, healthcare professionals and healthcare industry. Its professionals usually have responsibility for the following general areas include ensuring that their industries comply with all of the regulations and laws, and working with local, state and federal regulatory agencies such as the Food and Drug Administration or European Medicines Agency on specific issues affecting their business. Obtaining a new medicine to market is a unique process based on a number of requirements for supporting a product launch. New antibody drug conjugate treatments are used these days.


Management of Medical Affairs provides the quality clinical data by ensuring the adherence to SOPs and GCP under ICH recommendation guidelines and maintains the ICH-GCP compliance. Generally, Pharmaceutical industries have two types of scientific teams, one of Medical Affairs services and another for research and development. Research and development describes the initial stage of development and scientific method, as well as includes clinical trial runs, while its services provide scientific support for the end stage of development and post marketing. 

A function of its services includes delivering technical backing to internal teams as well as external consumers, and field-based medical information specialists who provide in-depth drug and disease information to health providers. Its services deliver information to ensure that consumer queries are adequately addressed and distribute data to health care providers in the community. Its team also frame plans, review, publications and report of important clinical trial results to the Pharmaceuticals and medical devices agency (PMDA), in scientific meetings or by providing journal articles etc.

Department of research and development of industry, may look to be an issue for someone else to handle in the far-distant future and at a much later time from launching a product into the market but even at laboratory or early development stages, biotechnology industries should understand the language of pharmaceutical industries and know how that industry operates and make early decisions regarding their investigations products that could lead to future success.

Global Allied Pharmaceuticals (GAP) has industry trained specialists in Medical Oncology.  In biotechnology, there is no real equivalent to medical affairs; still it plays an important role in the pharmaceutical industry that highlights its importance both in pre launch and during the launch of new medicine. We provide several services include Product Development & Commercialization, Market Access, Regulatory & Quality and Market Intelligence.
For more information, contact us at www.gapsos.com

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