LITIGATION CONSULTING & EXPERT WITNESS SERVICES

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LITIGATION CONSULTING & EXPERT WITNESS SERVICES

REJIMUS provides specialized regulatory and scientific expertise for law firms in the Food, Beverage, Dietary Supplement, and Cosmetic industries. Our team of highly trained and experienced quality and regulatory experts offers controlled documentation system practices to support matters involving labeling and marketing claims, analytical testing, product safety, contaminations or adulterations, counterfeit products, patent infringement, breach of contract, adverse events, ingredient or product recalls, and much more. We cover all areas of Regulatory Affairs, Quality Assurance, Quality Control, Ingredient and Product Testing, Product Complaints, Formulation, and Safety within the industries we support.

Expert Witness Services

REJIMUS also provides Expert Witness services for Food or Food Ingredients, Dietary Supplements, Dietary Ingredients, Cosmetics, Packaging, Homeopathic products, and Medical Foods. Our support includes:

• Establishing Content, Use, Labeling, and Structure/Function Claims
• Guiding Investigation and Discovery
• Label Misrepresentation or False Branding
• Breach of Contract or IP infringement support
• Regulatory Guidance & Interpretation
• Consumer Fraud or Adverse Events
• Expert Opinion
• Depositions and Court Testimony for Civil and Criminal Matters

GMP, Quality & Regulatory Consulting

For litigation matters involving GMPs, Quality Control, or Regulatory Operational issues, REJIMUS provides 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. Our support includes:

• 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 Decrees
• Direct oversight for Product Complaints, AERs, SAERs, and Product Recalls
• General Regulatory, Quality, and/or Scientific Consulting Strategy support

Partner with REJIMUS for comprehensive and reliable regulatory and scientific support in the Food, Beverage, Dietary Supplement, and Cosmetic industries.

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