Importance of Regulatory Affairs & Skills- by Rajashri Ojha

Regulatory affairs is a crucial function in the Indian pharma industry.
Industries like pharma , biologics, Nutra,food and medical equipment can be uncertain if the new products and methods are not tested and checked for functionality with great vigilance before being publicized. The first and foremost factor for the pharma sector has been always in
the time and occupied by the drug candidate to see the light of the day which is very in-dispensable for the product’s success and for the pharma companies.
Therefore, effective administration and superintendence of regulatory affairs
actions plays a crucial job towards economy of the corporation.
The regulatory affairs professional is the only person who is completely
responsible for such activities, as developing distinct rejoinders to regulatory
authorities who want an organization to hold products in compliance and retain satisfactory data in support of applications that have made for the registration of the products.
However, failure of the same may make the company to put a stop to on-time confident appraisal of the marketing submissions. A new entity can cost several millions of rupees or dollars to progress.
Surprisingly, even a few month deferrals in taking it to the market can have substantial impact on the monetary status of the company. One of the vital activities of the regulatory specialist is to ensure that the label of the product and related information of the patient has correctly been established and even a small mistake in any of the regulatory activities can make
the product to be ready for recall in addition to the loss of several millions of
money which is eventually bound to give rise to fall in self-assurance of financiers, health experts and finally the patients.