For law firms that specialize in the Food, Animal Feed, Dietary Supplement, Cosmetic or Homeopathic industries, we have experts on staff and thorough documentation practices to support matters involving claim substantiation, adulterated or counterfeit products, patent infringement, breach of contract, adverse events, recalls and much more. Our regulatory and scientific expertise covers all areas of Regulatory Affairs, Quality Assurance, Quality Control, Product Complaints, Formulation and Safety within the industries we support.
• Establishing Content, Use and Structure/Function Claims
• Label Misrepresentation or False Branding
• Breach of Contract or IP infringement support
• Regulatory Guidances & Interpretation
• Consumer Fraud or Adverse Events
• Expert Opinion
GMP, Quality & Regulatory Consulting
For Litigation matters involving GMP’s, Quality Control or Regulatory Operational issues, we can provide hands-on support for such work either on-site or remotely, inclusive of documentation reviews, investigational evaluations, SOP writing, Corrective And Preventative Action (CAPA) Planning, Quality System Design, Compliance Training and much more.
• 483 Responses including GMP Gap Investigations and CAPA reports
• FDA Warning Letter Responses, SOP Writing and Training
• Compliance Investigations and Due Diligence
• Litigation Support for Injunctive Relief or Consent Decree’s
• Direct oversight for Product Complaints, AERs, SAERs and Product Recalls
• General Regulatory, Quality and/or Scientific Consulting Strategy support