RAW MATERIAL INGREDIENT SUPPLIERS
Developers and manufacturers of excipients, specialty active ingredients and raw material blends face unique challenges when it comes to managing quality and ensuring compliance. Whether building a new manufacturing facility from the ground up, implementing a new quality documentation system or developing a new ingredient to enter the market, we have experts that can guide at every stage of your business in the US and abroad.
For Novel Ingredients
For New Ingredients
• NDI Evaluations and Electronic Submission – Do you have a New Dietary Ingredient (NDI) to file with the FDA? Are you sure you need to file an NDI? We can assist in the review, preparation and electronic submission of your NDI with greater success than the 20% industry average – typical turn-around times are 6-8 weeks for submission.
• GRAS Evaluations, Self-affirmations, and FDA Submission – For GRAS Self-affirmation with Expert Panel reviews or GRAS Notifications with FDA submission, we can assist with the development, management and submission of GRAS notices from start to finish.
• Raw Material Specifications & Ingredient Data Sheets
• Quality System Documentation – SOPs, Recording Keeping
Facility Design & Production Optimization
• Facility Auditing
• Quality System Optimization
• Manufacturing Facility Design
• Quality Personnel Hiring/Training Support
• Adulteration and Ingredient Recall Planning/Support
• Support for FDA Inspections and Responses
Ingredient Development Strategy Support
• Conducting International Regulatory Due Diligence
• Support for Permitting, Facility Registrations, Certificates of Free Sale
• Claims Development & Claims Substantiation for new ingredients to support future sales/marketing efforts
483 Form Observations and Warning Letters
We provide consulting for FTC actions, FDA Inspection, Form 483’s and Warning Letter responses as well as GMP compliance planning for 21 CFR Part 111, 110 and 101, as well as budgeting and guidance for restructuring of quality and regulatory operations. Whether we take the lead support of an FDA inspection to ensure future compliance including the hand-on writing of standard operating procedures (SOPs) and specifications, or close out investigations and adverse events, we have the scalability to meet the most demanding of deadlines.
Areas of support include:
• Dietary Supplement Consulting
• FDA Response Letters, CAPA Planning, Facility and Vendor GMP Audits
• Claim Substantiation, Website Content and Claims Reviews
• Product Development and Analytical Testing Strategy Support
• Quality Program Optimization and Gap Analysis
• Compliance Operations Planning & Implementation
• Formulation Data Sheets (FDS) and Ingredient Data Sheets (IDS)
• Quality Agreement for Laboratories, Manufacturers and Distributors
For ingredient suppliers engaged in a litigation matter requiring quality or regulatory expertise, we have the right team to support the issue in question. We have very thorough reporting and documentation practices, in addition to regulatory and scientific expertise for litigation consulting on class action, injunction, due diligence and infringement issues.
We provide law firms and/or in-house counsel of ingredient suppliers or novel ingredient manufacturers with litigation consulting in all areas of Regulatory Affairs, Quality Assurance, Quality Control, Product Complaints, Formulation and Safety. Specific areas supported include scientific record keeping and facility auditing, investigation, off-label marketing reviews, formulation evaluation, contamination or adulteration issues and counterfeit products. All reports and data are presented in a litigation ready format.
REJIMUS provides Litigation Consulting and Expert Witness services for matters involving Food or Food Ingredients, Dietary Supplements, Dietary Ingredients, Cosmetics, Packaging, Homeopathic products and Medical Foods.
• 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