OUR SERVICES

Whether you’re looking for expert auditing, targeted training, flexible QA/RA coverage, or ongoing strategic partnership, we offer a range of services designed to meet you exactly where you are. Explore the options below to find the solution that best fits your team’s needs, your compliance goals, and the stage of your product’s journey.

Regulatory &
Quality Auditing

  • Internal audits aligned with ISO 13485, MDSAP, and 21 CFR 4, 11, 210, 211, 820

  • EU regulatory audits including EU GMP Part I & II

  • Compliance assessments against ICH, IPEC, and ISO 14971 risk‑management requirements

  • Supplier and contract manufacturer audits

  • Sterilization process audits (EtO, gamma, e‑beam, steam)

  • Gap analyses and remediation planning

  • Audit readiness for FDA, notified bodies, and global regulatory authorities

Training &
Capability Development

  • Customized training on FDA regulations (21 CFR 4/11/210/211/820)

  • ISO 13485:2016 and MDSAP requirements explained through practical, real‑world examples

  • EU GMP Part I & II, ICH, IPEC, and ISO 14971 workshops

  • Sterilization fundamentals and validation expectations

  • Complaint handling, CAPA, and risk‑mitigation best practices

  • QMS document creation and training

On‑Demand QA/RA Support

  • Temporary or fractional QA/RA staffing to fill expertise or capacity gaps

  • Interim roles such as QA Manager, RA Specialist, or Compliance Lead

  • Hands‑on support with complaints, investigations, CAPA, risk mitigation, and QMS document creation

  • Assistance with sterilization documentation, validations, and regulatory expectations

  • Flexible hourly, project‑based, or short‑term engagement models

Retainer‑Based Consulting

  • Guaranteed access to senior QA/RA experts for ongoing guidance

  • Monthly or quarterly support packages tailored to your operational needs

  • Proactive compliance monitoring across ISO 13485, MDSAP, FDA, EU GMP, ICH, IPEC, and ISO 14971

  • Ideal for startups, small teams, or organizations without full‑time QA/RA staff

  • Regulatory & Quality Auditing

    •

    Internal audits aligned with ISO 13485, MDSAP, and 21 CFR 4, 11, 210, 211, 820

    •

    EU regulatory audits including EU GMP Part I & II

    •

    Compliance assessments against ICH, IPEC, and ISO 14971 risk‑management requirements

    •

    Supplier and contract manufacturer audits

    •

    Sterilization process audits (EtO, gamma, e‑beam, steam)

    •

    Gap analyses and remediation planning

    Audit readiness for FDA, notified bodies, and global regulatory authorities

  • Training & Capability Development

    •

    Customized training on FDA regulations (21 CFR 4/11/210/211/820)

    •

    ISO 13485:2016 and MDSAP requirements explained through practical, real‑world examples

    •

    EU GMP Part I & II, ICH, IPEC, and ISO 14971 workshops

    •

    Sterilization fundamentals and validation expectations

    •

    Complaint handling, CAPA, and risk‑mitigation best practices

    QMS document creation and training

  • On‑Demand QA/RA Support

    •

    Temporary or fractional QA/RA staffing to fill expertise or capacity gaps

    •

    Interim roles such as QA Manager, RA Specialist, or Compliance Lead

    •

    Hands‑on support with complaints, investigations, CAPA, risk mitigation, and QMS document creation

    •

    Assistance with sterilization documentation, validations, and regulatory expectations

    •

    Flexible hourly, project‑based, or short‑term engagement models

  • Retainer‑Based Consulting

    •

    Guaranteed access to senior QA/RA experts for ongoing guidance

    •

    Monthly or quarterly support packages tailored to your operational needs

    •

    Proactive compliance monitoring across ISO 13485, MDSAP, FDA, EU GMP, ICH, IPEC, and ISO 14971

    •

    Ideal for startups, small teams, or organizations without full‑time QA/RA staff