Navigating Regulatory Pathways with Precision

Strategic insight for pharmaceutical innovators worldwide with 30+ years of combined experience and 1000+ successful global submissions across FDA, EMA, MHRA, DCGI, Health Canada, and ROW markets.

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Trusted Experts in Pharmaceutical Consulting

With 30+ years of combined industry knowledge and 1000+ successful submissions, we provide strategic solutions built specifically for small and emerging pharmaceutical companies. Our expertise includes 25+ years of regulatory agency audit experience across global markets.

30+ Years Combined Experience
1000+ Successful Submissions
25+ Years Audit Experience
7 Global Markets

Our Expertise

  • U.S. FDA regulations (GMP, GLP, GCP)
  • Health Canada guidelines
  • EU frameworks
  • Global submissions (INDs, NDAs, ANDAs, BLAs, MAAs)
  • Post-approval lifecycle management

Why Choose iCure

  • Proven success with regulatory milestones
  • Domestic expertise with global reach
  • Long-term commitment to your success
  • Trusted professionals with industry recognition
  • Strategic solutions for emerging companies

Audit Excellence & Compliance

Comprehensive audit support with 25+ years of experience handling regulatory agency inspections and compliance assessments across FDA, EMA, MHRA, DCGI, Health Canada, and ROW markets.

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Facility Audits

Thorough facility assessments ensuring compliance with global pharmaceutical manufacturing standards and regulatory requirements across all major markets.

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CGMP Audits

Current Good Manufacturing Practice compliance audits covering all aspects of pharmaceutical quality systems and operations with proven track record.

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Regulatory Agency Audit Support

Expert preparation and support for regulatory inspections with 25+ years of successful audit handling experience across global agencies.

Regulatory Agency Expertise

FDA

U.S. Food and Drug Administration

EMA

European Medicines Agency

MHRA

UK Medicines and Healthcare products Regulatory Agency

DCGI

Drug Controller General of India

Health Canada

Canadian health regulatory authority

ROW Markets

Rest of World regulatory authorities

Comprehensive Pharmaceutical Services

From regulatory strategy to quality assurance, we provide end-to-end support for your pharmaceutical journey.

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Regulatory Affairs

Strategic regulatory roadmaps and dossier preparation for global markets including FDA, Health Canada, EMA, MHRA, DCGI, and ROW submissions with 1000+ successful cases.

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Quality Assurance

Custom Quality Management Systems aligned with cGMP, FDA, EU, Health Canada, MHRA, DCGI, and global regulatory requirements backed by 30+ years experience.

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Facility & CGMP Audits

Comprehensive facility and CGMP compliance audits with 25+ years of regulatory agency audit experience across FDA, EMA, MHRA, DCGI, Health Canada, and ROW markets.

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Business Setup

Turnkey solutions to get your business operational and inspection-ready from Day 1 across global markets with proven track record.

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R&D Consulting

Expert solutions to keep your development programs on track with formulation and analytical support leveraging 30+ years of combined expertise.

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Licensing & Registration

Complete support for FDA registrations, state licenses, controlled substance licensing, and global market registrations with comprehensive regulatory expertise.

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Compounding Pharmacy

Full-service support for compliant compounding pharmacy establishment and operations with global standards and regulatory compliance assurance.

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Labeling Solutions

Compliant label content and artwork development for human and veterinary products across all global markets with proven regulatory expertise.

Specialized Solutions

Tailored approaches for different stages of your pharmaceutical journey.

Regulatory Excellence

Comprehensive support for all regulatory pathways including expedited designations and complex submissions across 1000+ successful cases. Navigate FDA, EMA, MHRA, DCGI, Health Canada, and ROW requirements with confidence backed by 30+ years of expertise.

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Quality Management

Phase-appropriate QMS implementation with inspection readiness and compliance assurance backed by 30+ years experience. Build robust systems that grow with your business and maintain audit readiness.

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Audit Readiness

Complete audit preparation and support for facility, CGMP, and regulatory agency inspections with proven 25+ year track record across FDA, EMA, MHRA, DCGI, Health Canada, and ROW markets.

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Latest Insights

Stay informed with our expert analysis and industry perspectives.

AUDIT EXCELLENCE

Mastering Global Regulatory Agency Audits: 25+ Years of Expert Insights

Strategic approaches for successful FDA, EMA, MHRA, DCGI, and Health Canada inspections based on decades of experience.

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QUALITY COMPLIANCE

CGMP Facility Audit Best Practices for 2025

Essential elements for maintaining audit-ready pharmaceutical facilities with comprehensive compliance frameworks.

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REGULATORY STRATEGY

Navigating 1000+ Submissions: Lessons from Global Regulatory Success

Key insights from successful submissions across major pharmaceutical markets with proven track record.

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Ready to Get Started?

Let's discuss how we can help accelerate your pharmaceutical journey.

Contact Information

Location:
Plainsboro, NJ, United States
Business Hours:
Monday - Friday: 9:00 AM - 6:00 PM EST

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