Government Regulation - Codes Standards Consultants: 6

James M. Dorsey, PhD, is an expert on Geopolitics with an emphasis on China, India, Eurasia, and the Middle East, as well as on Sports Governance and the relationship between sports and politics.

Dr. Dorsey is a senior fellow at the S. Rajaratnam School of International Studies at Singapore’s Nanyang Technological University, a syndicated columnist, and the author of the blog, The Turbulent World of Middle East Soccer. 

For several decades, Dr. Dorsey served as a foreign correspondent for The Wall Street Journal, The New York Times, and the Financial Times based in Asia, the Middle East, and the Americas, and has been a university-based analyst for the last ten years. He is widely published and consulted by governments, financial institutions, corporations and political risk companies and departments. He is a two-time Pulitzer Prize finalist, as well as a finalist in several other award competitions.

Dr. Dorsey is a member of the Pre-Goals Advisory Council to the Emir of Qatar, a member of the Advisory Conference on Building World Class Stadiums, and a member of the Advisory Board European Water Partnership.

Consulting Services - Dr. Dorsey's ideal client engagement includes consultation with governments, financial institutions, corporations, and political risk companies with respect to geopolitics in his regions of study, and specifically on:

Dr. Dorsey is also available to consult where sports and politics are at issue internationally.

Tom Jonaitis, DABT, is a Board Certified Toxicologist and Product Safety / Regulatory Consultant with 18 years of experience. He has broad expertise in the areas of Safety and Exposure Assessment, Regulatory Compliance, and Toxicology Evaluations.  

Mr. Jonaitis helps companies efficiently navigate and comply with various regulations and obstacles in the consumer product, food, cosmetic, dietary supplement, and chemical industries. His has co-authored several manuscripts in peer-reviewed journals on the topics of safety, risk assessment, and other research.

Background Experience - Prior to forming RegTox Solutions, Mr. Jonaitis served as Manager of Toxicology & Regulatory Affairs at Intertek Scientific & Regulatory Consultancy (2005-2018). He worked as subject-matter expert (SME) and client contact for matters related to California Proposition 65, including presenting webinars and presentations. He also conducted human exposure assessments in relation to chemicals in food, dietary supplements, consumer products, cosmetics, as well as deriving exposure limits for carcinogens, reproductive / developmental or other toxins using traditional and benchmark dose modeling approaches.

Business Consultant Services:

• Regulatory Compliance Evaluations
• Scientific Literature Hazard Reviews and Summaries for Chemicals / Substances
• Creating Pre-Market Quality and Safety Dossiers for Novel Food / Dietary Supplement Ingredient Applications (primarily for US, Canada, Australia)
• Safety Assessments
• Label Claims Analysis and Compliance
• Deriving Exposure Limits
• HazComm, Pesticide Applications, and various other niche areas
• California Proposition 65 Compliance (and how to avoid costly enforcement)

Principal, John Lawrence Stevens, RAC, has over 20 years of FDA Regulatory Compliance experience encompassing virtually all FDA field positions. He also has 18 years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the Medical Device Industry, including several large and small cardiovascular companies. 

Mr. Stevens has personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel which reviewed over 30 PMA clinical studies for cardiovascular devices. He regularly perform webinars regarding FDA and issues regarding Clinical Studies and Medical Devices.

View Mr. Stevens' Expert Witness Profile.

Carlo Scevola & Partners is an International Fiduciary Company headquartered in Geneva, Switzerland, with branches in six continents. We specialize in International Planning, Strategic Consulting and Wealth Management. Our clients trust us for everything from setting up an Offshore Company to Mergers and Acquisitions to Business Finance and Asset Protection. 

CS&P’s customer-centric methodology ensures that each client gets a custom-tailored solution which addresses that business’ individual objectives and requirements. Our team has expertise in every functional category and every important geography. From finance to operations to human resources to marketing – from the Americas to Europe to Africa, Asia and Oceania – CS&P can bring together experienced executives who know how to advise you and will make your enterprise a success. All this while always protecting your privacy. 

Services Offered: Business and Strategic Consulting

• S.W.O.T. Analysis
• Pre-investment Feasibility Studies / Competitive Background Assessments
• Business Plan Research, Writing and Production
• Strategy Definition / Implementation
• Reworking of Operating Processes for International Suitability
• Industrial Partnership Scouting / Matching
• Tailor Business Model to Market Environment, Jurisdiction and Local Authorities Requirements 

Corporate Finance:

• Mergers, Acquisitions and CessionsCommercial Due Diligence or Investment / Financial Appraisals
• Company Reorganization and Restructuring
• Financial Feasibility Plans for Industrial Expansion
• Scouting / Recruiting Highly Qualified Financial Management
• Exit Strategies in the event of Buy-outs, Buy-ins, Spin-offs or MBOs, MBIs and LBOs
• Listing on Stock Exchanges 

Offshore Consulting:

1. International Tax Planning
2. Corporate Structuring, Maintenance and Trusts
3. International Contracts Law
4. Jurisdictions
5. Residency and Citizenship
6. International Banking
7. Logistic Support
8. Government Licenses
9. Aircrafts and Vessels
10. Intellectual Property 

CS&P Operates In More Than 80 Countries Around The World.

Specializing in GOVERNMENT CONTRACTS AND SUBCONTRACTS, Christoph Mlinarchik, JD, CFCM, PMP, is an attorney, former federal contracting officer, professional instructor, top consultant, frequent public speaker, and prolific author of 50+ publications, including the three bestselling books in The Government Contracts in Plain English Series. 

Christoph has negotiated, reviewed, or managed billions of dollars of government contracts over the course of his career.  This real-world, US government and private-sector contractor experience provides an invaluable perspective for clients, including information technology (IT), professional services, defense, cybersecurity, construction, medical/health care, intelligence, national security, research, science, technology, and several other sectors.

Christoph has taught or trained 1000+ federal, military, and contractor professionals nationwide—from novices to C-level executives. Businesses and individuals rely on Christoph’s expertise to navigate the complexities of the federal contracting marketplace.

Consultant Services:

On Demand / Proposal Consulting - Federal Acquisition Regulation (FAR) or Defense FAR Supplement (DFARS) issues, clauses in government contracts or subcontracts; request for equitable adjustments or claims; contracting officer disputes or subcontract issues

Professional Training and Instruction - Bring general counsel up to speed on government contracts; prepare sales teams to market and sell to the federal government; give contracts staff the skills and knowledge they need to be effective professionals

Keynote Speaker and Panelist - Experienced and dynamic public speaker and makes government contracts exciting, having headlined at National Contract Management Association (NCMA), American Proposal Management Professionals (APMP), and other industry trade groups. Makes complex ideas simple, including federal contracting, changes to FAR and DFARS clauses, bid protests, small business set-asides, subcontracts, and big issues in government contracting

View Christoph Mlinarchik's Expert Witness Profile.