Pricing Summary for FDA Compliance and Consulting Services

At Verus IP, we offer expert FDA compliance and consulting services to support biotech and AI-driven innovations in navigating the complex regulatory landscape. Our pricing reflects the specialized expertise required to ensure your products meet FDA standards for safety and efficacy. Below is an overview of our core services and starting rates. Contact us for a customized quote tailored to your project.

Core FDA Compliance Services

Pre-Market Regulatory Strategy

  • Initial Regulatory Assessment: Starting at $5,000
    Comprehensive evaluation of your product (e.g., biologics, medical devices, or AI-based diagnostics) to determine FDA requirements and pathways.

  • 510(k) Submission Preparation: Starting at $15,000
    End-to-end support for Class II medical device clearance, including predicate device analysis and documentation.

  • Pre-Market Approval (PMA) Support: Starting at $50,000
    Strategic guidance and documentation for Class III devices or high-risk biologics requiring rigorous FDA review.

  • Investigational New Drug (IND) Application: Starting at $25,000
    Preparation of IND submissions for clinical trials, including CMC, preclinical, and clinical protocol development.

Clinical Trial Support

  • Clinical Trial Design Consulting: Starting at $10,000
    Development of FDA-compliant protocols for biotech or AI-driven trials, ensuring alignment with regulatory expectations.

  • FDA Meeting Preparation: Starting at $7,500 per meeting
    Support for pre-IND, Type B, or Type C meetings, including briefing package preparation and rehearsal.

  • Data Monitoring and Compliance: Starting at $15,000
    Oversight of clinical trial data integrity and regulatory compliance, including GCP audits.

Post-Market Compliance

  • Quality System Regulation (QSR) Implementation: Starting at $20,000
    Development and implementation of FDA-compliant quality systems for manufacturing and post-market surveillance.

  • Adverse Event Reporting Support: Starting at $5,000
    Assistance with Medical Device Reporting (MDR) or pharmacovigilance requirements.

  • Post-Market Surveillance Plan: Starting at $10,000
    Design of FDA-compliant surveillance programs to monitor product safety and performance.

AI and Software-Specific Consulting

  • SaMD (Software as a Medical Device) Compliance: Starting at $15,000
    Guidance on FDA requirements for AI-driven diagnostics or therapeutic software, including validation and cybersecurity.

  • De Novo Classification Support: Starting at $25,000
    Assistance for novel AI or biotech devices requiring a new regulatory pathway.

  • AI Algorithm Validation for FDA: Starting at $12,000
    Support for validating AI/ML models to meet FDA’s Good Machine Learning Practice (GMLP) guidelines.

Additional Services

  • Regulatory Gap Analysis: Starting at $7,500
    Detailed audit of your current processes to identify and address FDA compliance gaps.

  • FDA Inspection Readiness: Starting at $10,000
    Preparation for FDA audits, including mock inspections and staff training.

  • International Regulatory Support: Quoted per jurisdiction, starting at $10,000
    Harmonization of FDA compliance with global standards (e.g., EU MDR, Health Canada).

  • Training and Workshops: Starting at $5,000
    Customized FDA compliance training for your team, covering GMP, QSR, or AI-specific regulations.

Billing and Customization

  • Hourly Rates: $300–$800/hour, depending on consultant expertise and project complexity.

  • Flat-Fee Options: Available for most submission preparation and assessment services for cost predictability.

  • Custom Packages: Tailored solutions for startups, large pharma, or AI-driven companies with unique regulatory needs.

Why Choose Us?

  • Specialized Expertise: Deep experience in biotech and AI, including gene therapies, AI diagnostics, and medical devices.

  • Proven Success: Track record of successful FDA submissions and compliance programs for innovative products.

  • Client-Centric Approach: Transparent pricing and strategic guidance to accelerate your path to market.

Get Started: Contact us at info@verusip.com or 833-210-5003 for a free consultation and customized quote. Let us guide your biotech or AI innovation through FDA compliance.

Note: Prices are subject to change based on project scope, product complexity, and regulatory requirements. FDA filing fees and third-party costs (e.g., testing labs) are additional.