LIFE SCIENCE GRANTS AND CONTRACTING SUPPORT

LIFE SCIENCE GRANTS AND CONTRACTING SUPPORT

Pharmaceutical and biotech companies looking to fund the clinical development of their products by contracting with the Department of Health and Human Services (DHHS), Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense (DOD), Defense Threat Reduction Agency (DTRA) face unique challenges not encountered by commercial companies or companies doing business with other Federal agencies.

At Capital Edge Consulting, we have the most experienced team in the industry, working with companies contracting with BARDA and DTRA and its unique requirements.

From assistance with developing the white paper proof of concept and proposal development through contract execution and close-out, we will be your partner throughout the entire process.

WHITE PAPER SUPPORT

Working with your technical team, we help you estimate the costs associated with your technical approach and compile compliant, aligned cost estimates to provide BARDA or DTRA with a rough order of magnitude for advancing your product towards licensure.

PROPOSAL DEVELOPMENT

Once your w has been accepted and the government has requested a formal proposal, we will work with your team to develop a cost volume that aligns with your technical volume and ensures maximum recovery of contract costs.

This includes:

• Direct labor cost calculations,
• Contract research organization pricing,
• Subcontract/consulting pricing,
• Indirect rate calculation,
• Structure fee analysis.

CONTRACT NEGOTIATION

A critical step in the process of contract award, the negotiation stage, provides an opportunity to ensure your company does not assume too much performance and cost risk through the contract type and procurement method employed.  This stage of the process is where we look to ensure we maximize cost reimbursement and profit.

Areas we focus on during negotiations included:

• Rate cap discussions,
• System capability justification,
• Structure fee/profit approach,

SYSTEM DESIGN

Government contracting requires internal controls and the implementation or enhancement of key business systems to ensure your company can properly and consistently estimate, account for, and bill for costs incurred under government contracts.

These systems include:

• Accounting,
• Timekeeping,
• Labor distribution,
• Indirect rates,
• Estimating,
• Earned value management systems (EVMS),
• Purchasing,
• Government property,
• ON-GOING COMPLIANCE

We work with you to determine the proper level of controls needed as your government business grows and look for ways to minimize system investments along the way.

Once the contract is awarded, we work with you to meet all of the contract administration requirements including:

• Subcontract/consulting preparation of Consent to Subcontract package to the agency,
• Monthly cost review and reconciliation,
• Monthly reporting and invoicing including EVMS,
• Annual incurred cost submission.