Our Expertise

Comprehensive Safety Assessment & Regulatory Compliance

At Indivirtus Healthcare Services, we specialize in providing FDA GRAS compliance and cosmetic safety report EU services for non-pharmaceutical industries. Our expert team ensures your food additives, cosmetic ingredients, and consumer products meet stringent global regulatory requirements. From GRAS evaluation services to detailed CPSR preparation, we guide you through complex regulatory landscapes, enabling successful market entry across multiple jurisdictions while maintaining the highest safety standards.

FDA GRAS compliance and CPSR preparation services

Our Specialized Safety & Compliance Services

Our Proven Safety Assessment & Compliance Process

Initial Consultation & Strategy Development

We begin with a comprehensive review of your product, intended use, and target markets. Our experts develop a tailored regulatory strategy that identifies the most appropriate pathway for compliance, whether through GRAS evaluation services, CPSR preparation, or alternative regulatory routes based on your specific requirements and timeline.

1

Data Collection & Gap Analysis

Our team conducts thorough data gathering and scientific literature reviews to assess existing safety information. We perform detailed gap analyses to identify any missing studies or documentation required for FDA GRAS compliance or cosmetic safety report EU preparation, ensuring all regulatory requirements are addressed comprehensively.

2

Expert Safety Assessment & Documentation

Qualified safety assessors and toxicologists conduct rigorous safety evaluations following FDA and EMA guidelines. We prepare comprehensive safety dossiers, coordinate expert panels when required, and ensure all assessments meet the stringent standards required for successful regulatory submissions.

3

Regulatory Submission & Agency Interaction

We prepare and submit all required documentation to relevant regulatory authorities, including FDA GRAS notifications and EU competent authority submissions. Our team manages all agency communications, responds to queries, and provides ongoing support throughout the review process to ensure timely approvals.

4

Post-Approval Support & Compliance Monitoring

Following successful approvals, we provide ongoing compliance support including post-market surveillance guidance, regulatory updates, and assistance with any required modifications or renewals. Our team ensures your products maintain compliance with evolving regulatory requirements across all target markets.

5

Regulatory Framework & Compliance Standards

FDA GRAS Requirements

  • 21 CFR Part 170 - Food Additives Generally Recognized as Safe
  • Self-Affirmed GRAS pathway documentation and expert consensus
  • FDA GRAS notification submission requirements (21 CFR 170.36)
  • Safety data evaluation and dietary exposure assessments
  • Manufacturing specifications and quality control standards

EU/UK Cosmetic Regulations

  • Regulation (EC) No 1223/2009 - EU Cosmetics Regulation compliance
  • UK Cosmetics Regulation post-Brexit requirements
  • CPSR Part A (safety information) and Part B (safety assessment)
  • Qualified Safety Assessor evaluations and certifications
  • Product Information File (PIF) compilation and maintenance
  • CPNP notification and labeling compliance

Additional Regulatory Frameworks

  • EFSA Novel Food Regulation (EU) 2015/2283 compliance
  • FDA MoCRA safety substantiation requirements
  • SCCS Guidelines for cosmetic ingredient testing
  • Good Manufacturing Practice (GMP) assessments
  • Global market entry strategies and regulatory harmonization

Partner with Indivirtus for Expert Safety Compliance

Navigating the complex regulatory landscape for food, cosmetic, and consumer products requires specialized expertise and deep understanding of global compliance requirements. Indivirtus Healthcare Services offers comprehensive GRAS evaluation services, expert CPSR preparation, and strategic FDA GRAS compliance support to ensure your products meet the highest safety standards. Our experienced team of regulatory professionals, toxicologists, and safety assessors provides end-to-end support from initial consultation through post-market compliance, enabling successful global market entry with confidence.

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Frequently Asked Questions

Frequently Asked Questions

What is GRAS and why is it important for food ingredients? +

GRAS (Generally Recognized as Safe) is an FDA designation for food ingredients considered safe by qualified experts. GRAS status allows ingredients to be used in food without requiring premarket approval as food additives, providing a faster pathway to market while ensuring safety.

What is a CPSR and when is it required? +

A Cosmetic Product Safety Report (CPSR) is mandatory under EU Regulation 1223/2009 for all cosmetic products marketed in the EU/UK. It provides scientific evidence that a product is safe for human use under normal conditions and must be prepared by a qualified safety assessor.

How long does the GRAS evaluation process take? +

GRAS evaluation timelines vary: Self-Affirmed GRAS typically takes 6-9 months, while FDA GRAS notification can take 12-18 months including preparation and review time. The timeline depends on data availability and complexity of the ingredient.

What services does Indivirtus provide for regulatory compliance? +

Indivirtus provides comprehensive GRAS evaluation services, CPSR preparation, FDA/EMA compliance consulting, safety assessments, expert panel coordination, regulatory submissions, and ongoing compliance support for food, cosmetic, and consumer products.