Regulatory Affairs department plays a pivotal role in driving the R&D efforts of the company to the market.It takes a lot of time for a product to make its final presence in the market.And Its the regulatory affairs department which is responsible for getting timely market approvals.Delay in getting market approvals can effect the market share and revenue thus generated. And the only success lies for the pharmaceuticals is timely market approvals from regulators.
So to get the timely approvals,the pharmaceuticals either should have a regulatory departmennt with strong regulatory knowledge or they should get all the approvals outsourced through regulatory consulting firms.
In Today's scenario,with changing global regulatory norms.Outsourcing regulatory work seems to be beneficial and less time consuming rather than making a large regulatory department which is time consuming and is expensive.And the consultants needs to update their knowledge in current regulation, so as to make the approval process less time consuming.
There are many regulatory consulting firms which outsource regulatory work both at large scale and small scale. Outsourcing regulatory work depends upon core competencies which varies from outsorcing firm to firm and on the quality of work provided by a outsourcing firm which in turn depends on the regulatory affairs professionals employed.Regulatory firm hired by the customer company can surely expedite the regulatory approval process if the customer company shows the active participation.
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