Comprehensive Regulatory Consulting and Compliance Solutions
We provide cost-efficient regulatory consulting services to companies in the Food and Beverage, Dietary Supplement, Cosmetic, and Homeopathic/OTC industries at every stage of their respective supply chains. Quality Control and Regulatory procedures need to be developed, implemented and optimized as part of a comprehensive cGMP Quality System required by law, inclusive of establishing appropriate labeling before entering the marketplace.
Best Compliance Practices are the principles we’ve developed to ensure the right systems are in place and that they are aligned with your business goals, including your Regulatory Management Practices, Facility Design and Product Development Strategy. All projects are managed with very high degree professionalism, exceptional business ethics and an important sense of urgency. Guidance and expertise are useless without action, and REJIMUS works with you to reach the final steps of implementing and resolve quicker to fully maximize fruits of your labor.
Regulatory Consulting Services
• FDA Regulatory Consulting and FDA Compliance
• FDA Inspection Support and Response Planning
• Quality Systems Design & Implementation
• Technical Documentation Development (e.g. SOP’s, FDS, IDS)
• Product and Ingredient Risk Evaluations
• FSMA, Food Safety Plans, FSVP, HACCP to HARPC Conversions, Food Defense Plans and Exemptions
• Project Management & Contract Service Contract Negotiation
• Novel Ingredient Submissions (GRAS Dossiers and NDI Notifications)
• Labeling, Claims Substantiation and Marketing Content Review
Organizational Compliance Services
• cGMP Facility and Vendor Audits (Manufacturing, Warehousing and Distribution, Importing, Outsourcing)
• Gap Analysis, Quality System Optimization, Loss Investigations
• Supply Chain Optimization, Import Detention Support and Relief
• Market Research and Customer Intelligence Research
• Reduced Ingredient Testing Strategies for Raw Materials and Finished Products
• Regulatory Market Evaluations
• Accreditation Planning, GMP Auditing and Inspection Support
• Quality Program Optimization and Restructuring Support
• Adverse Event Reporting Management
• Brand Reputation Support, Social Media Monitoring, Crisis Mitigation
Expert Support Services
• Litigation Consulting & Expert Witness
• M&A Support, Due Diligence
• Adulteration & Counterfeit Investigations
SPEAK WITH AN EXPERT
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Frequently Asked Questions
What regulatory consulting services does REJIMUS offer for food and beverage companies?
REJIMUS’s regulatory consulting services for food and beverage companies include FDA compliance support, inspection preparation, quality systems design, technical documentation, and guidance on regulatory submissions such as GRAS notices.
How does REJIMUS help with FDA compliance and inspection support?
REJIMUS helps with FDA compliance and inspection support by assessing regulatory requirements, strengthening quality systems, preparing documentation, and guiding businesses through inspections and corrective actions.
What are the benefits of using REJIMUS for quality systems design and technical documentation?
The benefits of using REJIMUS for quality systems design and technical documentation include cost-efficient expert support to build practical, regulation-aligned systems, strengthen compliance, and prepare clear documentation for FDA requirements and industry best practices.
What regulatory services does REJIMUS provide for cosmetics?
REJIMUS provides cosmetics regulatory consulting, including FDA compliance support, inspection preparation, quality systems design, and technical documentation to help businesses meet applicable requirements.
How does REJIMUS handle dietary supplement compliance?
REJIMUS handles dietary supplement compliance by helping businesses meet FDA requirements and best practices through regulatory guidance, quality systems support, technical documentation, and expert consulting.
What is involved in novel ingredient submissions?
Novel ingredient submissions involve preparing and submitting regulatory documentation—such as GRAS notices for food ingredients or NDI notifications for dietary supplements—to support an ingredient’s safety and compliance with FDA requirements.
How does REJIMUS support OTC product manufacturers?
REJIMUS supports OTC product manufacturers with FDA compliance guidance, quality systems design, technical documentation, and inspection support to help them meet regulatory requirements and maintain best compliance practices.
What GRAS submission services are offered by REJIMUS?
REJIMUS offers GRAS submission support to help businesses prepare and navigate Generally Recognized as Safe submissions for food ingredients, including regulatory documentation and compliance guidance.
How are NDI submissions handled by regulatory experts?
NDI submissions are handled by regulatory experts through assessment of ingredient data, preparation of the required safety and technical documentation, and support with FDA submission requirements and follow-up.
What quality systems design services does REJIMUS offer?
REJIMUS’s quality systems design services include developing and improving compliance-focused systems tailored to businesses in food and beverage, dietary supplements, cosmetics, and OTC products.
How does REJIMUS assist with FDA inspection readiness?
REJIMUS assists with FDA inspection readiness by helping businesses strengthen quality systems, organize compliance documentation, identify gaps, and prepare for inspections through expert regulatory guidance.
What technical documentation support does REJIMUS provide?
REJIMUS’s technical documentation support includes developing and reviewing regulatory documents for food, beverage, dietary supplement, cosmetic, and OTC businesses to help meet applicable FDA requirements and industry best practices.
How can companies contact REJIMUS for expert support?
Companies can contact REJIMUS for expert support by submitting the website’s contact form to discuss their regulatory, compliance, or quality systems needs.
What industries benefit from REJIMUS regulatory consulting?
The industries that benefit from REJIMUS regulatory consulting include food and beverage, dietary supplements, cosmetics, and over-the-counter (OTC) products.
How does REJIMUS ensure food and beverage compliance?
REJIMUS ensures food and beverage compliance by helping businesses meet applicable FDA requirements and best practices through regulatory consulting, inspection support, quality systems design, and technical documentation.
What compliance practices does REJIMUS help implement?
The compliance practices REJIMUS helps implement include FDA regulatory compliance, quality management systems, inspection readiness, technical documentation, and best practices tailored to food, beverage, dietary supplement, cosmetic, and OTC businesses.
How does REJIMUS structure its cost-efficient consulting services?
REJIMUS structures its cost-efficient consulting services around each company’s regulatory needs, offering focused support in FDA compliance, quality systems, documentation, and inspection readiness across regulated industries.
What legal requirements does REJIMUS help businesses meet?
The legal requirements REJIMUS helps businesses meet include FDA regulations and applicable compliance requirements for food and beverages, dietary supplements, cosmetics, and over-the-counter products.
How do experts at REJIMUS navigate complex regulations?
REJIMUS experts navigate complex regulations by applying industry-specific regulatory knowledge, interpreting requirements, and providing practical support with FDA compliance, quality systems, documentation, and submissions.
What organizational compliance solutions does REJIMUS offer?
REJIMUS’s organizational compliance solutions include designing and improving quality systems, developing compliance procedures and documentation, and providing expert support to help businesses meet regulatory requirements and follow best practices.
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