Regulatory CMC Contractors for Small Biotech Company

Client background

This small, established biotech company is focused on novel biological and drug delivery technologies.  They have over 100 employees and multiple approved products.

Challenge

Due to some recent turnover on their team, the Head of Regulatory Affairs was seeking a Regulatory CMC contractor to support all Regulatory CMC activities for several months.  This includes writing DMF and CMC sections for INDs, along with change controls and life cycle management.

Approach

Dennis Partners identified 40 Regulatory CMC contractors at the Manager level.  Within three days of starting the search, Dennis Partners produced four strong candidates who fit the designated criteria for the contract position.  

Result

The client interviewed candidates by phone and video meetings.  Within a week they decided to hire two of the contractors because they really liked both of them.  Dennis Partners assisted in checking references and getting the contractors set up for weekly timesheets.  Within two weeks from the start of the search, both contractors were able to start working remotely and have been able to make significant contributions to the client’s Regulatory team.  The client was very happy that we were able to deliver two great contractors who met their needs in such a short amount of time!