Strengthening governmental regulatory compliance for emerging global biopharmaceutical manufacturer
This case study highlights an emerging biopharmaceutical manufacturer that was months away from launching their first drug in the U.S., and needed help with complying with governmental regulations.
Client background
A global, U.S.-based emerging biopharmaceutical manufacturer that was months away from launching their first drug in the U.S.
The business challenge
The client decided not to invest in the infrastructure and systems, but recognized that they needed to comply with U.S. government regulations. Senior leadership recognized the risks of non-compliance in this complex area and needed an outsourced solution and team they could trust.
The approach
- We coordinated with the client on the various timelines and informed leadership about the governmental programs and what is involved
- We provided support for the company on the various tasks and worked with their internal and external counsel to develop a project plan, standard operating procedures (SOPs), policies and reasonable assumptions
- We worked with their third party logistics on data transfers, and created a methodology document and process for ongoing government price reporting
The business impact
The immediate result was having their drugs covered in the various programs at time of launch. In addition, it provided a lower cost and footprint for the company to maintain. It also provided the company trusted advisors that could not only perform the necessary steps for their Centers for Medicare & Medicaid Services (CMS) and Veterans Affairs (VA) reporting, but also provide additional analysis prospectively with a team that understands their products and company.
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