Quality Assurance and Compliance
Comprehensive Solutions for Quality Excellence
Achieve unparalleled quality assurance and regulatory compliance with our expertly tailored solutions. We specialize in establishing and enhancing Quality Management Systems (QMS) to align with industry best practices and GMP standards.
Our Services Include:
GMP Gap Analysis: Identify and address deficiencies in your operations to meet GMP standards with a tailored action plan.
QMS Development: Build a robust QMS that ensures product quality across your organization.
SOP Development and Review: Develop and optimize SOPs for consistency and operational efficiency.
Regulatory Compliance: Stay ahead with the latest regulatory standards for global compliance.
Internal Audits: Regularly assess your systems to ensure ongoing compliance and identify areas for improvement.
Training & Education: Empower your team with GMP training and quality assurance best practices.
Corrective and Preventive Actions (CAPA): Address quality issues with structured investigation and implementation strategies.
Documentation & Record-Keeping: Maintain compliance through meticulous record-keeping practices.
Vendor Management: Ensure supply chain reliability and compliance.
Recall Management: Prepare and execute effective recall strategies to mitigate risks.
PQR (Product Quality Review): Conduct periodic quality reviews for ongoing compliance and improvement.
Why Choose Us?
With our expertise, you can safeguard product quality, ensure regulatory compliance, and build a strong foundation for operational success.
We are committed to the success of your products and to help you develop and implement regulatory and quality solutions catered to your needs.
Our team of consultants bring many years of combined experience in Regulatory Affairs, Compliance and Quality Assurance, working with regulatory bodies around the world such as the TGA, Medsafe, FDA, EU Competent Authorities and Notified Bodies, and various global Authorized Representatives with a proven track record of executing techniques in a timely and cost efficient manner.