Cosmetics - Hair and Skin Care Products Consultants: 3

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: 

Tom Jonaitis, DABT, is a Board Certified Toxicologist and Consumer 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, building material, 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)

Meyer R. Rosen FRSC, FAIC, CPC, CChE is a leading creative consultant for the Legal Profession and specialty Chemical / Personal Care Industries. He is the Founder and President of Interactive Consulting, Inc. (www.chemicalconsult.com). 

Meyer is a Forensic Litigation expert for both plaintiff and defense in hazardous chemicals, products liability, personal injury, fires and explosions, intellectual property and trade secret cases. He also provides Technical Marketing, New Business Development, Technical Consulting and Professional Editing services internationally to the Specialty Chemical, Personal Care, Cosmetic, Pharmaceutical, Medical Device, and Allied Industries. 

Meyer also has 15 years of experience as a Professor of Fire Technology at Westchester Community College. Mr. Rosen is Editor- in- Chief of Harry’s Cosmeticology, 9th Ed. A 2,600-page trilogy on all aspects of the cosmetic industry (www.harryscosmeticology.com) as well as being Emeritus-Editor-in-Chief for EuroCosmetics magazine (Germany) and Editor-in-Chief of the Delivery System Handbook.  

Technology Expertise (Intellectual Property/Chemical Industry): Mr. Rosen provides consultation and litigation support in patent infringement, trade secret issues, and licensing matters. His scientific areas of expertise include, but are not limited to:

• Organosilicones: Surfactants, Emulsions, Foams, Antifoams, Silane Coupling Agents
• Water Soluble Polymers, Poly(ethylene oxide), Polyethylene Glycol, and Poly (acrylamide) and Water Insoluble Polymers
• Colloid and Surface Chemistry: Stability of Dispersions, Wetting & Spreading Phenomena, Suspensions & Emulsions, Clays, Paint & Coatings, Personal Care, Cosmetics
• Flocculating and Coagulating Agents
• Applied Rheology, Rheology Modification of Aqueous & Non-Aqueous Media

Certifications:

• Chartered Chemist and Fellow: Royal Society of Chemistry – London
• Nationally Certified Professional Chemist and Professional Chemical Engineer
• Fire and Explosion Expert (Advanced Training)
• Fellow: American College of Forensic Examiners
• Fellow: American Institute of Chemists
• Diplomate: American Board of Forensic Examiners
• Diplomate: American Board of Forensic Engineering and Technology

View Meyer Rosen's Expert Witness Profile.