AO Regulatory Consulting maintains an extensive library detailing the regulatory requirements for pharmaceutical and drug development companies. As a whole, these documents are referred to as regulatory intelligence and they include things like regulatory precedent, statutory requirements, policies, guidelines, and guidance. Monitoring and analyzing this library can lead to earlier strategic regulatory actions with the potential to significantly reduce your product development timeline. With a minimal 40 hour/month contract, AO Regulatory Consulting will give your company access to this valuable repository.
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- Is a Pre-IND Meeting really needed?If polled, most executive teams would say they don’t want to take the time to do a Pre-IND meeting before submitting an initial investigational new drug (IND) application. I get it, it takes time, and time is money. But consider it can take MORE time to get your IND through… Read more: Is a Pre-IND Meeting really needed?