Product Safety Consultants: 20

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)

More than 40 years experience: defective packaging; unreasonably dangerous products; failure-to-warn; materials-handling; warehousing; cargo loading and securement; falling cargo; insurance claims for loss or damaged cargo; falling merchandise; patent infringement; trade-dress infringement. Has testified in state and federal courts and knows how to connect with a jury. Has worked for Plaintiffs and Defendants. Services: consulting; analysis; cite inspections; exemplar testing; opining; report writing; testifying. Long list of attorney references. Self-employed consultant. Former employee at Fortune 100 firms. Former university instructor. Many published articles and speaking engagements. Knows how to combine theory and practice.

Summit Associates of Bedford is a Materials and Manufacturing firm offering growth strategy, operations improvement, and international sourcing to commercial clients ranging in size from $3 to $150 million.

Summit Associates has a record of fixing troubled organizations and driving growth in complex technology based operations. Skilled at positioning small and middle market companies for sustained growth, they have commercial experience in ten countries, including creation and oversight of global partnerships in Europe and India and acquisition, sale, and licensing of fifteen technologies in seven countries.

Consulting Services:

Turnaround Leadership Organizational Change and Alignment Accelerated New Product / Market Development Product Launch

Lean Manufacturing Technology Acquisition Sale and Licensing International Partnerships Technology Valuation

Principal, Thomas W. Caldwell, PE, has over 40 years of experience in Materials Research and Development, Process and Product Development, and Manufacturing Operations in the Precision Cast and Machined Products industry.

Mr. Caldwell has designed and manufactured components for consumer and industrial products, including safety-critical applications such as aircraft landing gear brakes, seat belt lockup devices, windshield wiper, and window lift motor systems. He has experience creating and guiding technology development and manufacturing partnerships in Europe and Asia, licensing and selling intellectual property and creating supply chains in China.

Mr. Caldwell has lectured in the USA, Germany, Switzerland, and India on manufacturing premium quality metal products and manufacturing processes, and was a technical paper peer reviewer for 20 years for the Society of Automotive Engineers. A United States patent holder, he has published peer reviewed research in electrochemistry and materials processing, and has written and spoken numerous times on the subject of Materials Selection.

View Thomas A. Caldwell's Expert Witness Profile.

Susan Maccoy is a talented hair artist, image consultant, beauty educator and Consultant to the Professional Beauty and Hair Care Industry. As a consultant, she has been engaged by salon product manufacturers for product development, hair color formulation, hair color marketing, salon product and service marketing, as well as professional hair color and style education. As a master hair colorist, Ms. Maccoy played a leading role in the development of hi-lighting techniques using foil, and has trained professionals internationally in those procedures. As an educator, Ms. Maccoy has taught classrooms and lectured both nationally and internationally. She is the winner of Today's Chicago Woman Reader's Choice Award, the Clairol Hair Fashion Award, and Glemby International's Outstanding Achievement Award. Ms. Maccoy is also the creator and developer of the ProWorks™ Professional line of hair care products and ReikiRocks Spa Products™ and has consulted with such clients as Barbara Walters, Princess Diane Von Furstenburg, the Princesses Hussein of Jordan, and Lucille Ball among others. In her book, Down the Shampoo Bowl - The ABC's of Hair Salon Management, Ms. Maccoy explains the management and financial side of the beauty business and how to motivate employees, handle difficult clients, and promote business and services through traditional channels and social media. Consulting, Testing, Product Development and Education Development:

• Clairol Professional, Inc.
• Helene Curtis
• Glemby International
• Alberto Culver
• Nancy Flynn Marketing Resources Inc.
• Lynch and Associates, P.C.

Special Appointments / Qualifications:

• Member, Clairol Presidential Haircolorists' Council
• Research consultant, American Longevity Research Institute
• Salon member, American Society for Aesthetic Medicine
• Advanced Accredited Educator, NCBTMB

View Expert Witness Profile.

Timothy A. Anderson, MS, MBA, is a former FDA Review Chemist, with over 43 years of career experience in Pharmaceutical R&D, Quality Operations, and Regulatory Affairs. A uniquely interdisciplined individual, he melds comprehensive pharmaceutical industrial R&D, business development, QA/QC, and consultancy experiences with formal FDA-tenured regulatory credentials. 

As a consultant in his own pharmaceutical development advisory firm for over 29 years, Mr. Anderson has furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls (CMC), to current Good Manufacturing Practice (cGMP), quality system regulation (QSR) audits for finished dosage, and active pharmaceutical ingredient (API) manufacturing, as well as for device, drug-device combination, and biologic products.  Technical and regulatory compliance due diligence services are furnished to institutional investors.  

Mr. Anderson has contributed to regulatory approvals for over 50 drug and drug / device applications, spanning generic (ANDA) and innovator NDA, BLA, 510(k), PMA, and 505(b)(2) applications, and has provided regulatory compliance remediation services to resolve Form 483, Warning Letter, and Consent Decree issues. 

Clients have included Medtronic Ave., Allergan, Memorial Sloan-Kettering Cancer Center, Mass Biologics, MDS Pharma, US Pharmacopieia, Boehringer Ingelheim, BristolMyers Squibb, Genzyme, Intelliject/Sanofi, Church & Dwight, CR Bard/Davol, Ximedica, Fresenius-Kabi (Austria), KRS Biotechnology Ajanta, and many more

Consulting Services: 

Global Regulatory Filing Review / Writing Agency Negotiation Strategic Advisories

Contracted Management Services Current Good Manufacturing Practices Compliance Quality Systems

View Timothy Anderson's Expert Witness Profile.