Global Pharmaceutical Company Case Study

Victura Consulting has worked alongside a global pharmaceutical company that develops, manufactures, and markets generic and branded pharmaceuticals. Beginning in early 2009, Victura professionals have assisted our Client with a wide range of services in relation to the Client’s on-going efforts with the U.S. Military to develop, approve and ultimately bring to full-scale production a critical vaccine to protect all military personnel across all service lines.  At the outset of our engagement, we assisted the Client with design and implementing the cost accounting structure necessary to comply with the requirements of performing the full CAS covered, cost reimbursable, development contract, with an estimated value of over $100 million.

Our continued relationship with the Client then transitioned to assisting the client in the preparation of multiple contract cost proposals for submission to the U.S. Military to manufacture and supply the vaccine after FDA approval was received for the vaccine.  All cost proposals were subject to meeting the Truth in Negotiations Act (TINA) (now Truthful Cost or Pricing Data Act) requirements.  Victura professionals assisted the client with all aspects of the cost proposal preparation including development of the multi-year cost estimate pricing models, drafting the proposal narratives (i.e. a Basis of Estimate), and preparing the necessary supporting documentation required to be submitted to the government. Victura assisted this client with the preparation of four complete cost volume proposals, all of which resulted successful contract award. The cumulative contract award value for this client exceeds $275 million.

In addition to the proposal assistance, we have assisted the Client with various on-going consulting and administrative assistance throughout the performance of the Development and various manufacturing contracts including the following (not all inclusive)

• Preparation of annual incurred cost submissions.
• Liaison and assistance with coordination and interactions with government auditors.
• Assistance with negotiation of contracts and resolution of audit findings.
• Assistance with maintaining accounting records for the Client’s government contracts.
• Assistance in preparation and successful close-out of 10 year cost reimbursable Development contract.