Navigate global regulatory complexities with our comprehensive regulatory strategy development and MoCRA compliance expertise
Achieve successful market entry across global jurisdictions through our expert FDA/EMA compliance consulting services, backed by deep regulatory intelligence and proven strategic guidance for complex regulatory landscapes.
FDA/EMA compliance consulting encompasses comprehensive regulatory strategy development for global market entry, ensuring products meet stringent international standards. Our services include MoCRA compliance implementation, novel food application support, regulatory intelligence, gap analysis, and ongoing compliance monitoring across multiple jurisdictions and product categories.
Professional regulatory consulting accelerates market entry, reduces compliance risks, and optimizes resource allocation through strategic planning. Our expertise ensures regulatory efficiency, prevents costly delays, facilitates agency interactions, and provides competitive advantages through deep understanding of evolving regulatory landscapes and emerging compliance requirements.
Food manufacturers, cosmetic brands, novel ingredient developers, and consumer product companies seeking global market expansion. Our services benefit organizations requiring regulatory expertise for FDA/EMA submissions, MoCRA implementation, international compliance strategies, and companies navigating complex multi-jurisdictional regulatory frameworks.
Our regulatory strategy development begins with comprehensive assessment of your products, target markets, and business objectives. We analyze regulatory requirements across jurisdictions, identify optimal pathways for market entry, and develop customized compliance strategies that align with your commercial goals and timelines.
For MoCRA compliance, we provide detailed implementation guidance covering facility registration, product listing, adverse event reporting, safety substantiation, and Good Manufacturing Practices. Our team ensures seamless transition to new requirements while maintaining operational efficiency and regulatory compliance.
Novel food applications receive specialized support through our EFSA expertise, including pre-submission consultations, comprehensive dossier preparation, safety assessment coordination, and ongoing communication with regulatory authorities throughout the evaluation process.
Our labeling reviews and claims validation services ensure compliance across multiple markets, covering ingredient declarations, nutritional information, health claims substantiation, allergen warnings, and mandatory regulatory statements while optimizing marketing effectiveness.
Comprehensive regulatory gap analysis identifies compliance deficiencies, assesses risks, and provides detailed remediation strategies. We maintain ongoing monitoring systems to track regulatory changes, update compliance frameworks, and ensure continuous adherence to evolving international standards.
Global Regulatory Strategy - Detailed market entry plans with jurisdiction-specific compliance roadmaps, timeline optimization, and resource allocation strategies
MoCRA Compliance Implementation - Complete assessment of current practices, gap identification, facility registration support, and ongoing compliance framework development
Novel Food Application Support - EFSA submission preparation, scientific dossier compilation, safety assessment coordination, and regulatory communication management
Labeling Compliance Review - Multi-jurisdictional labeling analysis, claims validation, regulatory statement verification, and marketing compliance optimization
Regulatory Gap Analysis - Comprehensive compliance assessment, risk evaluation, remediation strategies, and priority-based implementation plans
Ongoing Compliance Monitoring - Regulatory intelligence updates, compliance framework maintenance, change impact assessments, and proactive adaptation strategies
Agency Interaction Support - Pre-submission meetings, regulatory correspondence, query responses, and strategic communication planning with FDA/EMA authorities
Documentation and Training - Standard operating procedures, compliance manuals, staff training programs, and knowledge transfer for internal teams
Our consulting services encompass FDA regulations including the Modernization of Cosmetics Regulation Act (MoCRA), Federal Food, Drug, and Cosmetic Act (FDCA), and Good Manufacturing Practices, ensuring comprehensive compliance with U.S. market requirements and enforcement standards.
European regulatory compliance covers EU Novel Food Regulation, Cosmetics Regulation, EFSA guidelines, and EMA requirements, providing expert guidance through complex European authorization processes and ongoing compliance maintenance across EU member states.
International harmonization strategies align submissions across multiple jurisdictions, optimize resource utilization, and ensure consistency with global standards including ICH guidelines, ISO requirements, and regional regulatory frameworks for efficient multi-market compliance.
Our FDA/EMA compliance consulting supports diverse product categories including innovative food ingredients, functional foods, cosmetic formulations, dietary supplements, food additives, and consumer products requiring multi-jurisdictional regulatory approval and ongoing compliance management.
Market expansion strategies benefit companies seeking entry into new geographic markets, requiring regulatory intelligence, compliance gap analysis, and strategic planning for efficient resource allocation while meeting diverse international regulatory requirements and standards.
MoCRA implementation projects assist cosmetic manufacturers in transitioning to new FDA requirements, including facility registration, product listing, safety substantiation, adverse event reporting, and establishment of compliant quality systems and documentation frameworks.
Our services extend to regulatory modernization initiatives helping established companies adapt to evolving regulations, implement new compliance frameworks, optimize existing processes, and maintain competitive advantages through proactive regulatory intelligence and strategic adaptation.
Navigating complex global regulatory environments requires specialized expertise, strategic thinking, and deep understanding of evolving compliance requirements. Indivirtus Healthcare Services combines extensive regulatory experience with innovative consulting approaches to deliver comprehensive solutions for international market success.
Our expert team includes former FDA/EMA professionals, seasoned regulatory strategists, and industry specialists with proven track records across diverse product categories, providing clients with insider knowledge, strategic guidance, and practical solutions for complex regulatory challenges.
From initial regulatory assessment through ongoing compliance maintenance, our consulting services provide end-to-end support ensuring your products achieve successful global market entry while maintaining the highest standards of regulatory compliance and commercial viability.
The Modernization of Cosmetics Regulation Act (MoCRA) of 2022 is the most significant expansion of FDA authority over cosmetics since 1938. It requires facility registration, product listing, adverse event reporting, safety substantiation, and compliance with Good Manufacturing Practices for cosmetic manufacturers.
EU novel food applications typically take 18-24 months from submission to authorization. This includes initial review (1 month), EFSA safety assessment (9 months), and European Commission decision-making (7 months), excluding any additional information requests or delays.
Regulatory gap analysis includes comprehensive assessment of current compliance status, identification of deficiencies against applicable regulations, risk evaluation, detailed remediation strategies, implementation timelines, and ongoing monitoring frameworks to ensure continuous compliance.
We develop customized global market entry strategies including regulatory pathway analysis, jurisdiction-specific compliance requirements, submission timeline optimization, resource allocation planning, agency interaction support, and ongoing regulatory intelligence to ensure successful multi-market launches.