Services

At NovaReg, we offer a flexible approach to practical support tailored to your business and regulatory goals. Whether you're building your first Quality Management System (QMS) or planning for an FDA submission, we combine strategic insight with hands-on execution ensuring compliance without compromising momentum.

Quality Management Systems QMS Services

Quality and Compliance

Build or refine a QMS that scales with your growth.
We help companies design and implement compliant, efficient quality systems aligned with ISO 13485, MDSAP, and FDA QSR expectations. Our approach is pragmatic and risk-based - we right-size your QMS to your product type, team size, and commercial stage.

Services include:

  • Quality Management System (QMS) design and gap remediation

  • Internal audits and audit readiness support

  • CAPA system design and investigation support

  • Supplier qualification and controls

  • ISO 13485 and MDSAP implementation and maintenance

  • Document control and records management systems

  • QMS training for teams and leadership

Regulatory Strategy

Navigate complex global pathways with clarity.
We develop regulatory strategies that support market access, investor confidence and long-term success, across the US, EU, Australia, and beyond. Whether you're planning a 510(k), IVDR submission, or navigating classification, we provide strategic advice grounded in current regulations and expectations.

Services include:

  • Regulatory strategy development (FDA, TGA, EU IVDR/IVD-MDR, CLIA)

  • Regulatory pathway assessments and classification

  • 510(k), Technical Documentation, TGA applications and briefings

  • Pre-submission meeting support (FDA Q-submissions, EU consultations)

  • Labeling, claims, and promotional review

  • Clinical evidence planning (per IVDR, FDA, TGA)

  • Ongoing regulatory compliance and post-market support

Product Development Support

Accelerate innovation with structured, compliant development.
We guide product teams through the design and development process, helping align technical progress with regulatory expectations from the start. Our support ensures that your design history file (DHF), risk documentation, and performance evidence will stand up to scrutiny and support a smooth path to approval.

Services include:

  • Design control framework setup and documentation

  • Risk management file development (ISO 14971)

  • Performance evaluation planning (analytical + clinical)

  • Evidence gap assessments

  • DHF remediation and audit prep

  • Verification & validation planning support

  • Cross-functional training and coaching

How We Work

We tailor our services to your needs. Engagements range from short advisory projects to embedded support.

  • Project-based: Defined scope, fixed deliverables

  • Fractional regulatory lead: Ongoing senior support without the headcount

  • Review & gap analyses: Targeted review of existing systems or documents

  • Pre-market to post-market support: Full lifecycle engagement available