Since the world is advancing day by day, so as the pharmaceutical industry and hence the rules and regulations decided by the regulatory authorities. Medical and Clinical affairs professionals have a pivotal role in creating and designing the clinical studies and clinical trials. They are the pioneer in conducting and managing the studies and trials since the investigator meeting till the close out meeting. They perform a very vital task in report preparation which leads to the ultimate goal of the clinical research and trial.

It is the responsibility of the medical professional who work directly in close proximity of the operation team to direct and plan the overall clinical regulatory activities so that it can happens as per the norms decided by the regulatory authorities.

Firstly, they straightforward and provide inputs to the short and long term planning of initiatives in regulatory submission by managing regulatory teams and providing appropriate guidance. They assist in providing regular inputs for the things to be changed in ongoing projects and review of it. The expertise in clinical research confer with outside agencies as needed to resolve key regulatory issues and assist approvals of product and services. The changes and updates in the ongoing trials are provided to the staff and management by them. They provide regular training to team with updating regulatory requirement. They prepare and submit applications, reports, supplements and amendments to update registered product information.

The expertise monitors and updates national and international registration requirements through reviews of publications in the ongoing projects, seminars, and having direct correspondence with outside regulatory personnel. They also handle responsibilities like handling budget requirements and dealing with project and program costs. These professionals review the files, reports and evaluate it for further submission from drug discovery to market approval and making certain all actions are efficient and complete to maintain a professional report with FDA.

Clinical affairs collaborate with project teams to provide leadership for coordination in time and assembly of regulatory documentation for defining and explaining the details of what technical information is needed, and in what format to assure appropriate, accurate and complete submissions. Thereby, coordinating and preparing document packages for submissions to regulatory authorities and ensuring its compliance with the Food and Drug Administration.

It also includes monitoring and managing the distribution of products for single-center and multi-center studies to be sure that products are rapidly received and properly labeled and any delayed clinical studies are immediately reported.

Preparing outlines, summaries, status reports, graphs, charts, tables and slides for distribution and communication to other departments and provide guidance to project teams and staff.

GAP being a pharmaceutical company is growing since past 14 years. We are working towards the growth of pharma industry. We have a robust and hardworking team. To know more about us, visit www.gapsos.com.