Research & Development

Quality Management System and Regulatory Compliance Management:

A quality management system (QMS) is a set of business processes focused on achieving quality
policy and quality objectives to meet customer needs. It is stated as the organizational structure,
policies, procedures, processes and resources needed to implement quality management as per
regulatory requirement.
 Electronic document management
 SOP management
 Regulatory submission management
 eCTD management
 CAPA management
 Change control
 Deviation management
 Complaints management
 Audit management
 Learning management and training
Manufacturing and Regulatory Compliance:
Manufacturing compliance composed of the technical, legal and corporate requirements,
regulations and practices manufacturers must comply with in order to produce and market
products. The risk of non-compliance has become gradually major worry in recent years, mainly
for manufacturers with operations in multiple countries and jurisdictions. This development has
been further heightened by the increasing role of governmental regulatory bodies in industry
sectors, along with the emergence of global standards to talk the increasingly global nature of
manufacturing.
Marketing and advertising

 In most product areas where regulatory requirements are essential, restrictions are also
placed upon the claims which can be made for the product on labeling or in advertising.

 The regulatory affairs will take part in the growth of the product marketing concepts and
is usually vital to approve packaging and advertising before it is used commercially.

Drug Labelling Approval:

Reference:
Kanwal, N. (2015, November 21). Regulatory Affairs. Https://Www.Slideshare.Net/.
https://www.slideshare.net/NailaKanwal/regulatory-affairs-55362084?
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