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Regulatory Support

Navigating Global Regulatory Pathways with Confidence

Minaris Advanced Therapies provides comprehensive regulatory guidance for advanced therapy programs, encompassing all aspects from early development to commercial manufacturing. Our teams have effectively supported submissions to the FDA, EMA, PMDA, Health Canada and other global agencies, with a strong history of ensuring inspection readiness and achieving successful approvals.

Whether you’re preparing your first IND or maintaining a marketed product, we help you meet international requirements, anticipate regulatory changes and expedite market access. Our services can be provided as part of a comprehensive end-to-end CDMO program or as standalone support for specific regulatory milestones.

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Regulatory Excellence at a Global Scale

We maintain compliance with FDA, EMA, PMDA, MHRA, MFDS, TGA, and USDA requirements and operate under ISO/IEC 17025:2017 accreditation where applicable.

Our regulatory and quality teams have supported:

16 regulatory filings in
a two-year period

4 major regulatory
bodies approvals
75+ client audits annually
4 quality certifications
across global facilities

Our Regulatory Capabilities

  • Inspection Readiness and GMP Compliance

    Inspection Readiness and GMP Compliance

    Audit preparation, gap assessments, and mock inspections to align with global agency expectations. Support includes documentation, quality system review, and readiness planning for pre-approval and post-approval inspections

  • CMC Documentation and Submission Support

    CMC Documentation and Submission Support

    Preparation and submission of CMC packages for pre-IND, IND, IMPD, and BLA filings. Our experts ensure phase-appropriate, regulator-ready data across cell therapy, viral vector, and testing programs.

  • Drug Master File Management

    Drug Master File Management

    Creation, submission, and maintenance of Type II and Type V DMFs for cell lines, plasmids, facilities, and analytical methods, enabling sponsors to reference compliant, up-to-date manufacturing and testing information.

  • Assay Transfer and Validation for Regulatory Filings

    Assay Transfer and Validation for Regulatory Filings

    Onboarding, bridging, and validation of analytical methods to meet global regulatory standards, supporting product characterization, lot release, and stability programs.

  • Technology Transfer Documentation and Change Control

    Technology Transfer Documentation and Change Control

    Robust frameworks for transferring processes between sites or phases, ensuring traceability, quality, and regulatory compliance while minimizing program delays.

  • Integrated Testing for Submission Packages

    Integrated Testing for Submission Packages

    In-house biosafety, potency, characterization, and release testing data packages designed for regulatory filings and ongoing product lifecycle support.

Ready to Get Started?

Partner with Minaris to ensure your program is ready for global market entry. Whether you need inspection readiness, CMC authoring, or integrated testing packages, our experts will help you move forward with confidence.

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Minaris Advanced Therapies is dedicated to helping innovators in cell and gene therapy succeed. Whether you are in early-stage development or preparing for commercial launch, our end-to-end expertise, global reach and commitment to quality make us the ideal partner for cell and gene therapy manufacturing and GMP biosafety and analytical testing of all biologics.

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