As of May 5, 2017 submission of NDAs, ANDAs and BLAs to the Center for Drug Evaluation and Research (CDER) using the eCTD format became mandatory. For commercial INDs and Master Files the deadline is May 5, 2018.
But how do you know if your company is ready to go public? Here are 8 things to evaluate before considering taking your company public.
Selecting the right CRO to manage a clinical trial can be a critical decision in the program’s successful outcome. With so many CROs to choose from, what kind of evaluation criteria should be used?
In advance of the webinar, we sat down with Javier to discuss some of the nuances of structuring earnouts in M&A transactions and the implications for both the buyer and seller.
Everything you need to know about the Federal Anti-Kickback Statute and the Beneficiary Inducement Statute and how it affects your patient engagement program.
The therapeutic field of adoptive cell therapy (ACT) in cancer has expanded dramatically in recent years, both in investment activity and technology proliferation. Tune in to our web panel discussion to find out what experts think is in store for this exciting field.
Below are several areas of your company that will be scrutinized by a buyer and can potentially kill your deal.
Some recommended considerations for entering into an M&A process are highlighted below.
We recently sat with the experts at LMK Clinical Research Consulting to get their perspective on electronic Trial Master File (eTMF) challenges and best practices.
The healthy valuations achieved by sellers have been supported by lenders’ willingness to finance packaging acquisitions, with leverage multiples today sometimes surpassing 7.0x total debt / EBITDA.
