Life Sciences

TMO’s BioProcess Technology Group (BPTG) is the world leader in providing strategic, technical, regulatory, and business consulting services to the biopharmaceutical industry. We understand first-hand the challenges of developing and commercializing new products and technologies. BPTG provides flexible and responsive consulting services to help you through complex technical and regulatory issues allowing you to achieve your key business milestones.

BPTG offers full-service strategic CMC advisory and technical support across your product life cycle or targeted, short-term consultations (engagements) on specific technical, quality, regulatory, or operational issues. Our consultants are highly experienced thought leaders across various disciplines and provide actionable insight, targeted analyses, and solid strategies to help de-risk the technical, quality, and regulatory challenges of the development and commercialization of our products.

Regardless of your need, our expert team provide you with the thought leadership, integrity, and outstanding service you demand.

Every day, life sciences businesses are continuing to grow, in a multitude of ways. From considering M&A, raising capital, going public, or collaboration arrangements to extending operations overseas, these organizations want to expand their product portfolios – and expand into new markets. But these transactions are complex, multi-faceted, and create significant uncertainty regarding financial reporting. Businesses dealing with these issues require advisors with experience and insight into these arrangements and the many challenges that come with them.

That’s where TMO comes in. Our Life Sciences Practice provides the guidance that pharmaceutical, biotech, and medical device manufacturers need, when they need it. From understanding the complexities of research and development tax credits and FDA regulations, to licensing agreements and due diligence, we help our clients grow.

Accounting for Innovation
From M&A and IPO assistance to financial reporting and regulatory services, we help our clients meet their larger business goals – whether companies are investing in research and development, acquisitions, or new products.

Audit and Assurance Services
Our professionals around the world use a common global audit methodology that complies with International Standards of Auditing (ISA) and any applicable national or local country standards.

Advisory
TMO’s Advisory Practice provides transaction, risk, and executive services to clients navigating an exceptional range of challenges, changes, and opportunities. This includes everything from general corporate finance and real estate advisory services to forensic investigation and litigation support.

Tax Advisory and Compliance Services
We help our clients remain tax compliant – everywhere and anywhere they do business. Our full-service tax team is available to assist in any aspect of tax planning, revenue recognition, compliance, analysis, income tax accounting, due diligence, or other specialized tax area.

Investment Banking
TMO Capital Advisors, LLC, is a leading middle market investment bank with deep industry knowledge, extensive cross-border transaction experience, and superior execution capabilities. From acquisition advisory to business continuity and capital raising, our seasoned investment bankers have collectively advised on hundreds of transactions for a variety of clients.

TMO offers life science organizations a broad range of support, both for their current and potential government award portfolios in biodefense and pandemic response funded by:

• Department of Health and Human Services (HHS)
• Office of the Assistant Secretary for Preparedness and Response (ASPR)
• Biomedical Advanced Research and Development Authority (BARDA)
• Strategic National Stockpile (SNS)
• National Institutes of Health (NIH)
• Centers for Disease Control and Prevention (CDC)
• Department of Defense (DOD)
• Defense Threat Reduction Agency (DTRA)
• Department of Homeland Security (DHS)

Our team has extensive experience in the Life Sciences industry and within Government agencies. We regularly help our clients successfully navigate the compliance, cost accounting, and project management challenges associated with government contracts, grants, and Other Transaction Authority (OTA). We offer services in the following areas:

Compliance and Cost Accounting Implementation

• FAR/HHSAR/CAS/OMB-compliant internal controls and systems
• CAS disclosure statement development
• Indirect Rates
• Timekeeping system design
• Annual incurred cost submissions (ICS)
• Small business subcontracting plan development and tracking
• Earned Value Management (EVM) monitoring and reporting systems
• Outsourced project accounting and financial management
• Government audit support

Program Management & Project Management

• Subcontractor and risk management
• Government program/system integration
• Stakeholder management and communication
• Security plan development and training

Technical Consulting

• CGXP compliance
• Clinical operations
• Vendor and supplier management
• CMC technology transfers
• Drug substance and drug product manufacturing operations management