SUPPLY CHAIN
A DECLINE IN REVENUES FROM approved products and rising competition in generics is placing added pressure on resources at all pharmaceutical , biotechnology and medical device companies . Company resources continue to decrease and approval processes and post-approval requirements have become more complex .
Outsourcing can provide a solution and deliver a competitive advantage for companies that lack the resources or expertise to guide a product to approval . Companies , however , need to ensure the outsourcing partner they choose will fit within their current business structure . According to a white paper recently published by the Cardinal Health Regulatory Sciences team , there are four key factors that can help pharmaceutical and biotech companies become successful in choosing an effective regulatory outsourcing partner .
Know When to Consider Outsourcing Shortage of employees is one of the primary reasons companies choose to outsource during the regulatory approval process . Additionally , a company may have more products in development than internal staff is available to guide to approval in a timely manner .
External staff can alleviate both of these issues by handling routine regulatory maintenance so internal staff can focus their attention on highpriority development programs . Partnering with regulatory experts can also save valuable time and unnecessary work ; especially if there have been recent changes to regulations . By using such experts on an “ as-needed ” basis , costs can be minimized rather than keeping individuals on staff long-term .
Determine What Functions are Best Outsourced While entire pharmaceutical , biologic , or device
28 October 2014