A Smarter Way to Set Up and Operate in the USA

GTM Global in association with Frazier & Deeter and Thorelli Associates

7th March 2024 / 10:00 - 16:00 GMT

Frazier & Deeter
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QRx Partners

Organiser

GTM Global

When

Thursday 7th March 2024
10:00 - 16:00 GMT

Where

Frazier & Deeter London Office, 20 St Dunstan's Hill, London EC3R 8HL

Format

F2F 1-2-1 mentoring & bespoke advisory sessions. Book a two hour slot between 10:00 - 16:00.

Preparing for U.S. Market Entry Success: Expert Insights and Face-to-Face Guidance

Join us for an exclusive opportunity to engage on a face-to-face,1-2-1 basis with an expert panel of U.S. market entry, setup and compliance practitioners.

Are you a tech or digital scaleup looking to enter or expand your operations in the United States? Don't miss this chance to gain invaluable insights and get personalized guidance from top experts in legal, accounting, compliance, employment, operations and FDA regulations.

Key topics covered:

  • Risk mitigation on legal, tax and compliance issues
  • Prioritizing intellectual property protection
  • Setting up and structuring a U.S. company entity
  • Understanding the U.S. sales tax landscape, including state taxes
  • Finding the right employment and talent solutions
  • Locating in the right city for your business needs
  • Obtaining local grants and incentives

Why attend this London Drop-in Clinic?

Invaluable insights to support your expansion plans
  • Face-to-face meetings with US compliance and talent experts Mike Whitacre, Tom Thorelli, Laurie Spicer and Mark Swanson: You'll have the opportunity to meet with Mike, Tom, Laurie and Mark in-person and receive tailored advice on a smarter way to set up and operate in the USA.
  • Expert advice from leading U.S. firms: Get personalized guidance from Thorelli & Associates on setting up in Delaware, IP and immigration, Frazier & Deeter on accounting, tax, structuring and financial compliance, Foothold America on US employment and compliance, hiring options and HR and talent management, and QRx on FDA advisory matters, ideal for life science businesses.
  • Critical operational factors for U.S. market entry: From establishing a corporate structure to protecting your IP, finding funding and managing talent, our experts will provide bespoke tips, advice, guidance and insights on a 1-2-1, confidential basis.
  • Connect with key U.S. partners and resources: Through the GTM team, you'll have the chance to connect with U.S. commercial partners, funders, economic development boards, universities, and accelerator programs.

Event Advisors

Key regional expansion experts

Legal Framework and Market Entry with Tom Thorelli

Thomas Thorelli, Founder

Thorelli Associates is a Chicago based law firm that works exclusively with UK and European tech companies looking to enter or expand in the US markets. Areas of expertise include:

U.S. Market Entry and Compliance

  • Understand the U.S. market from a legal perspective.
  • Navigate federal and state regulatory environments.
  • Learn about data protection, intellectual property rights, and privacy laws.

Intellectual Property (IP) Protection

  • Establish a strong IP strategy to protect your technology.
  • Navigate the U.S. patent system and trademark filings.

Contract Law and Negotiations

  • Expertise in drafting and negotiating contracts that comply with U.S. standards.
  • Secure advantageous terms in licensing and distribution agreements.

Product Liability and Litigation

  • Mitigate risks associated with product liabilities.
  • Develop strategies to avoid potential litigation.

Business Structure

  • Advice on the most suitable business entity for operations.
  • Guidance on managing corporate governance and compliance issues.

Business Immigration

  • A strategy to maximize chances of obtaining visas.
  • Advise on types of visas available and when visas are needed.

Financial and Advisory Expertise from Frazier & Deeter

Malcolm Joy, UK Managing Partner

Frazier & Deeter is an Atlanta based US accounting firm with offices in the UK geared at supporting UK and European companies looking to setup and expand in the US market. Areas of expertise include:

Strategic Tax Planning

  • Tax structuring for efficiency and incentives.
  • Compliance with U.S. and international tax laws.

Assurance and Accounting Services

  • Financial reporting and GAAP compliance.
  • Importance of audits and assurance services for credibility.

Advisory Services

  • Business process optimization and internal control.
  • Financial and operational risk management.

Mergers and Acquisitions (M&A)

  • Conducting due diligence for M&A activities.
  • Advisory on transaction structuring for business goals.

Compliance and Regulatory Support

  • Navigating SEC regulations and Sarbanes-Oxley Act compliance.
  • Regulatory requirements for tech businesses.

Cybersecurity and Technology

  • Managing cybersecurity risks.
  • Leveraging technology for business efficiency.

Business Valuation and Financial Modelling

  • Valuation of tech business and intellectual property.
  • Financial modelling for growth and investment planning.

Operational and Employment Solutions from Foothold America

Laurie Spicer, Head of US Expansion

Foothold America, a Boston-based employment solution provider with offices in the US, UK, and Europe, offers comprehensive solutions for global businesses seeking to expand, recruit, hire, and oversee employees in the United States. Areas of expertise include:

Market Entry Services

  • Understand the US market from an employment perspective.
  • Identify the best US market entry solution based on your needs and provide turnkey solutions for scaling operations from market entry to maturity.
  • Receive support in establishing a business presence in the US quickly and compliantly.

Employment Solutions

  • Hire US employees without setting up a US entity.
  • Managing people operations for US employees hired directly through your US entity.
  • Support with recruiting the best talent for your business, ensuring cultural fit, and managing employment in 50 states.

Operational Support

  • Administrative functions, such as payroll and benefits.
  • HR support, including seamless onboarding and terminations, federal, state and local compliance, and risk management.
  • Talent acquisition below market cost and exclusively for our clients.

Streamlined Scaling

  • Quick market entry.
  • Flexibility to scale operations from market entry to maturity at your pace.
  • Save up to 50% on expansion costs.

QRX Partners Services

Mark Swanson, Healthcare Regulatory Advisor

QRx is a Minnesota based quality and regulatory service provider offering consulting services that ensure compliance and quality within the regulated life sciences industry, with a particular emphasis on personalized support to navigate the complex regulatory environment.

Range of Consulting Expertise

  • Specialization in consulting for Medical Device/IVD, Pharmaceutical/Biologics, Quality, Regulatory, FDA, MDR, including auditing, training, and education services.

Quality System Assessment & Auditing

  • Conducting thorough assessments to identify gaps and opportunities within existing systems.
  • Providing detailed quality system audits for medical device, pharmaceutical, biologics, and in vitro diagnostics sectors, as well as ISO 9001:2015, automotive, and aerospace industries.

QMS Development & Improvement

  • Developing Quality Management Systems (QMS) that offer value beyond mere compliance.
  • Enhancing existing QMS to elevate quality and ensure regulatory adherence.

Education & Training

  • Offering knowledgeable education and training services to ensure clarity and confidence in regulatory practices..
  • Emphasizing the importance of understanding over guesswork in quality and regulatory matters.

Regulatory Interaction Support

  • Assisting with preparation for, response to, and remediation of regulatory interactions.
  • Providing support across various stages of regulatory engagement to ensure effective communication and compliance.

Person Responsible for Regulatory Compliance (PRRC)

  • Ensuring satisfaction of EU requirements for the role of Person Responsible for Regulatory Compliance.
  • Addressing specific regulatory obligations within the European Union's regulatory framework.

Clinical/Performance Evaluation Reports

  • Authoring and reviewing Clinical Evaluation Reports (CER) and Performance Evaluation Reports (PER) for compliance and thoroughness.
  • Offering expertise in the critical analysis of clinical data and performance metrics.

Like to Get Involved?

If you’d like to become a partner or sponsor, we have a range of programmes and events you could get involved in.

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