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  • Home
  • Connect
  • About
    • About Us
    • Our Services
    • Our Global Reach
    • Conferences-Engagement
    • Blog
  • Focus
    • RWE/RWD
    • Radiopharmaceuticals
    • Pharmaceuticals
    • CMC
    • Rare Disease Therapies
    • Cellular Therapies HCT/Ps
    • Biologics
    • >> BLA
    • Combination Products
    • Medical Devices
    • >> 510k/PMA
    • Mergers & Acquisitions
    • Quality Management System
    • Regulatory Affairs

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Our Services

Comprehensive support specifically designed to address the unique challenges of developing and delivering therapies for rare and orphan diseases across the entire product lifecycle.

Support for the BioTech and Rare Disease Community

As your non-profit partner, our AI-driven platform and expert team provide strategic solutions to accelerate innovation, optimize trials, and ensure timely global patient access.

Global Regulatory Strategy & Submissions

Our platform leverages data analysis to provide expert guidance on navigating the complex regulatory landscape for rare diseases worldwide.

  • Developing strategies for Orphan Drug Designation (ODD) and expedited pathways (Fast Track, BTD, RMAT).
  • Transforming fragmented RWD to targeted RWE.
  • Aligning with requirements of global agencies (eg FDA/EMA).

Comprehensive Clinical Affairs RWE Support

We provide RWE clinical development services for rare disease research, addressing challenges like small patient populations.

  • Strategic and adaptive trial design and endpoint selection.
  • Strategizing trial extent based upon available RWE
  • Aiding in the identification and recruitment of diverse and underserved subjects.

Quality System Implementation & Auditing

We support the establishment of efficient, phase-appropriate **Quality Management Systems (QMS)** compliant with global standards.

  • Compliance with cGMP, ISO 13485, and ISO 9001.
  • Tailored services for complex rare disease manufacturing and supply chains.
  • Low-cost support for independent audits and site readiness.

Product Development & CMC Oversight

We provide strategic Chemistry, Manufacturing, and Controls (CMC) oversight from discovery through commercialization.

  • Phase-appropriate CMC strategy (IND/BLA/NDA) development.
  • Analytical method development and validation.
  • Manufacturing process scale-up and validation.
  • Supply chain and external partner (CMO/CRO) management.

Regulatory Compliance & Market Access

Expert support to address critical compliance issues and ensure the broadest possible patient access globally.

  • Response to agency concerns and Warning Letters.
  • Global supply chain compliance.
  • Specialized certifications: Halal, Kosher, and Animal-Origin Free.

Dedicated Support for Devices, Diagnostics & SaMD

Targeted regulatory and quality support for medical technologies crucial for rare disease management and treatment.

  • Support for AI-driven Software as a Medical Device (SaMD).
  • Navigating FDA , MDSAP, and EU MDR/IVDR requirements.
  • Compliance for ISO 13485, MDSAP, ISO 14971 (Risk Management) and ISO 10993 (Biocompatibility).

Areas of Therapeutic & Technology Focus

Areas of Therapeutic & Technology Focus

Our AI-powered platform and expert team provide support across various product types, always with a focus on applications targeting rare and orphan diseases and other therapeutic applications:


  • Small Molecule Pharmaceuticals (including repurposed drugs)
  • Biologics, Cell Therapies, and Gene Therapies
  • Medical Devices (including SaMD) for Rare Disease Management & Treatment
  • In Vitro Diagnostics (IVDR) & Companion Diagnostics
  • Combination Products tailored to Rare Disease Needs
  • Advanced Therapeutics (e.g., Vaccines, Nucleic Acid-based therapies)

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Regal Intel, Inc. is a 501(c)(3) public charity. All contributions are tax-deductible to the extent allowed by law. Copyright © 2025 Regal Intel - All Rights Reserved.

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