Cosmetics - Hair & Skin Care Products Expert Witnesses: 3

Timothy A. Anderson, MS, MBA, is a former FDA Review Chemist, with over 35 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 23 years, Mr. Anderson has furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls, 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

Litigation Support - Mr. Anderson has been deposed, testified in Federal Court, and functioned as a Subject Matter Expert Witness  and consultant to litigation in the Pharmaceutical, Biologic, and Device Life Sciences space, focused in areas of Anti-trust, Patent, and Product Liability.

Paul Chen is a Consumer Product (Non-Food) Safety, Regulatory and Retail Compliance, Quality Assurance and control, 3rd party lab testing / inspection / auditing, CPSC (Consumer Product Safety Commission), CPSIA (Consumer Product Safety Improvement Act), Federal / State / Local law compliance consultant and expert. He is on-call 24/7 and speaks Chinese fluently.

Background - Mr. Chen has over 17 years of experience in the Consumer Products Industry, most recently for the Product Safety & Compliance division at Walmart Stores, Inc. He was responsible for managing the regulatory compliance testing and auditing programs / policies / procedures / protocols / practices for general merchandise (non-food) items offered for sale in the Walmart, Walmart.com, Sam's Club, samsclub.com, and Puerto Rico formats. This included direct import, domestic, private label, supplier and national brand items in 20+ departments/categories.

In addition to being employed with the world's largest retailer (and company), Mr. Chen was also previously employed with Intertek, a global 3rd party test lab and QA/QC service provider and various consumer product companies, importers and manufacturers.

Litigation Support - Mr. Chen serves as an expert witness for attorneys representing plaintiff and defendant. His services include review, inspection, consultation, thorough reporting, depositions and trial testimony, as needed. Mr. Chen has experience in the following consumer products areas in various capacities: 

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Meyer R. Rosen FRSC, FAIC, CPC, CChE is a leading creative consultant for the Legal Profession, Specialty Chemical / Personal Care Industries. He is Founder & 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 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 Editor-in-Chief for EuroCosmetics magazine (Germany). 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)
• 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
• Certified 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 Consulting Profile.