Draft or update Review Policy and SOPs - When was the last time your Review Policy and SOP’s were updated?  Do you have these documents available? They would be one of the first things OPDP would request in the event of an issue. NuEra can help you write policy and SOP’s or simply update them. 

 

Conduct Training and Certification - It’s not enough to have the policies and SOP’s written, staff must be trained and certified annually. NuEra can provide training on policy and SOP’s, as well as a host of other relevant topics or we can customize a training program depending on your needs.

 

Comply with OPDP eCTD guidelines - The portal is up and running-are you ready?  Currently, use is voluntary, but, at some point, it may become mandatory. We can help you set up templates for ease of use and train your staff for an easy transition.

 

Simplify Your Audit Readiness Plan - Audits are something you always need to be prepared for, but hope never occur. We can assist you in developing or updating your Audit Readiness so you’re ready when, and if, you ever need it. We can do it quickly and cost effectively while you keep an eye on your daily business.