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REJIMUS

United States

Providing regulatory management consulting expertise in the following:
- Expert Witness and Litigation Consulting (for Sales, Business Practices, Regulatory, Quality, Packaging, Counterfeit Products, Claims, Contaminations, Recalls and more.)
- GRAS Self-determinations (or w/ FDA Notification) & New Dietary Ingredient (NDI) Notifications and Re-submissions
- FSMA, HACCP/HARPC, and FSVPs
- Writing/Reviewing Specifications, SOP's, Work Instructions, Study Protocols
- Logistical studies, transportation safety, and sanitation
- Business Strategy Planning and Transition Management for Quality and Compliance Operations
- USDA Level 2 Registrations, Permit Holder and Import/Export Support
- GMP Facility Auditing, FDA Warning Letter response support/planning (auditing, qualification or investigations)
- Ingredient and Product Label Reviews, Claims Substantiation and Dossiers
- Regulatory Scale-up Planning and Due Diligence for Products/Acquisitions
- Sales Process Design and Optimization
- Product Importation and Exportation Strategy Development and Support
- Quality Program Optimization & Troubleshooting

Trademarks

  • Ingredient Identity
  • moGMP
  • Best Compliance Practices
  • Rejimus
  • Formulation Data Sheet
  • Ingredient Data Sheet
  • HARPC
  • FSMA
  • GMP Compliance

Associations

  • American Botanical Council (ABC)
  • Organic Trade Association (OTA)
GMP Training - REJIMUS

GMP Training

NDI Notification, GRAS Submission - REJIMUS

NDI and GRAS

moGMP™ - Ingredient Identity

moGMP™

Claims Substantiation - Ingredient Identity

Claims Substantiation and Development

ELR and CLR - Ingredient Identity

ELR and CLR

BUSINESS RESOURCE SERVICES

FACILITY DESIGN

OUTSOURCED QUALITY ASSURANCE

LITIGATION CONSULTING

REGULATORY SUPPORT

SPECIFICATIONS

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