M&A Tech Due Diligence in Life Sciences

In 2023 and 2024, we are expecting significant M&A in life sciences.?As I captured in?my summary of the Ropes & Gray panel at #JPM2023, pharma companies with cash are going shopping. The financial constraints in the current market are going to create even more M&A opportunities.

With each acquisition, investment, or merger, there will be due diligence.?While life sciences due diligence primarily focuses on the science, the team, market opportunity, and clinical and regulatory risks,?in 2023, buyers should not overlook the opportunities and risks with data, technology and systems.

Most life sciences companies, VC and PE firms do not have in-house capabilities in these areas which is why?I have partnered with SVA Life Sciences (part of?SVA Consulting) to create a data and technology due diligence offering.

Mark Schafer?is SVA Consulting’s Chief Information Security Officer (CISO). He advises on?Cybersecurity and Risk Management in addition to contracting out to SVA life sciences clients as a virtual CISO.?His experience as a?Federal contractor, with CMS and DoD, and as a consulting CISO, is the?perfect complement to?my nearly 25 years of experience?with IT systems and compliance with biotech, pharma, med device, diagnostic, and digital health companies.

Together, we can provide risk and opportunity assessments for companies looking to invest in, acquire, or merge with other life sciences companies of all stages.?Areas include:

— Cybersecurity risk

— HIPAA compliance and risk

—GxP / 21 CFR Part 11 / Annex 11

— Data integrity

— GDPR / data privacy (including CCPA)

— Sarbanes-Oxley

— Quality systems

— General industry compliance (e.g., Sunshine Act)

Systems to include?(but not limited to): ERP/MRP, clinical, regulatory, quality assurance, eDMS, laboratory, quality control, manufacturing, medical affairs, adverse event reporting, complaint handling, HR, financial, eProcurement, budgeting/BPM/EPM, EH&S, facilities (including equipment maintenance/calibration), learning management, and PLM.

We tailor our due diligence services to meet your investment objectives?rather than adhering to a cookie-cutter, one-size-fits-all approach.

For more information or to schedule an initial call,?email Terri at [email protected] (415–793–5768) or?Andrew DeMarco?of SVA Life Sciences at [email protected] (608–239–7753).

SVA Life Sciences?assists life science leaders in successfully navigating their commercialization journey. By partnering with companies, we aim to mitigate risks associated with their initial launch through comprehensive planning, expert guidance for launch readiness teams, and by supplying seasoned professionals for efficient execution.

Solutions2Projects, LLC, a Silicon Valley-based consulting firm, offers specialized IT strategy and compliance services tailored to biotech, pharma, medical device, diagnostic, and digital health industries. Our comprehensive suite of services encompasses IT strategy development, vendor audits, system selection, GxP assessments, contract negotiation, and alignment with overarching corporate goals.