Streamlined regulatory review

While the efficiency of the NDA and BLA review process has greatly improved, dramatically decreasing the time for regulatory review, the same cannot be said for overall drug development time, from identification of a new drug candidate to NDA or BLA submission, which has resisted the anticipated streamlining effects of new technologies and efficiencies. 

There are no time limits for the review of company registrations by the regulatory authorities, and long delays are commonly experienced (up to three years, especially in Turkey and Oman). Furthermore, the bureaucratic process is also not streamlined. Legalizations by the equivalent of a Notary... 

Be on the lookout for opportunities to automate manual process and minimize training requirements. Seek out solutions that streamline data collection and regulatory research offering complex integration of multiple data sources, leaving more time for compliance analysis. Ensure that all proposed programs review and update data sources on a scheduled basis that is in keeping with jurisdictional requirements. 

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