Audits

• Internal: Assessing internal compliance with regulatory requirements, company policies, and quality standards while identifying opportunities for continuous improvement and audit readiness.
• Supplier Audits: Ensuring suppliers meet regulatory, quality, and industry best practices, while helping mitigate risks and drive corrective and preventive actions.

(Audits conducted to prepare for PAI, notified body, and certified body inspections, including 21 CFR Part 820, 21 CFR Part 4, 21 CFR Part 11, ISO 13485, ISO 9001, cGMP, MDSAP, MDR, IVDR, and more.)

Quality Management Development

Building complete, compliant QMS solutions with SOPs, work instructions, and records to achieve regulatory compliance and certification (ISO 13485, 21CFR820, ISO 9001, etc.).

Logistics Validation

Ensuring sensitive products are transported and stored under validated conditions that meet cleanliness, temperature control, and regulatory requirements.

Quality Management Gap Assessment and Remediation

Identifying compliance gaps, remediating deficiencies, and improving processes to strengthen operations and enhance customer confidence.

Quality Engineering

Providing technical oversight and developing, implementing, and maintaining processes and systems to meet regulatory and industry standards.

Regulatory

Preparing and submitting regulatory filings US and OUS (Outside of US) and providing regulatory guidance throughout the product lifecycle. Collaborating with cross-functional teams to ensure products meet necessary regulatory approvals and maintain market access.