Keep It Simple!
Over the last few months, I have been paying close attention to the many varied submissions that I have done on behalf of client companies and have come away with a clear strategy - keep it simple!
Because CL6 filings are reviewed by administrative staff - and often new and/or temporary administrative staff at that - the more complexity involved in a filing, the more likely the initial reviewer will have to turn to someone else with more experience for guidance. That, by definition, means delay. Sometimes a significant delay because the most senior administrative staff member, Ann Mone, has many varied job duties and many competing demands on her time. She cannot focus as much of her time as we would like on our submissions. But if a complicated filing with many pieces is broken down into several component parts, the chances of it staying with the initial staff member seem to increase and the approval times often improve dramatically.
The mechanics and construction of such a series of related submissions can be a little more complicated because they will likely need to be cross-referenced, but in my experience it is worth the effort because approval times improve dramatically! It is not uncommon for complicated CL6 filings to take 90 days, whereas a submission with just a single policy form and variable material is often processed in a couple of weeks. Given that tremendous difference, the extra effort up front will likely pay-off many times over when very short approval times result.
The risk with this approach is that one necessary piece will be delayed and, for example, the policy and riders are approved but the application is not. While that may be an uncomfortable situation to explain, the reality is that if the package had gone in together, everything would be held up, so the product launch is not delayed any more than it would otherwise have been.
