Quality Assurance and Compliance Services
Need a quality system overhaul or starting from scratch? Our team can assist with comprehensive documentation, training, and auditing services.
We offer comprehensive QMS services, from system design and implementation to staff training and auditing, to meet your specific needs.
We understand the critical importance of maintaining high product quality standards and adhering to regulatory requirements.
Our Services Include:
- GMP Gap Analysis: Identify areas where your operations may be falling short of GMP standards and develop a tailored action plan for compliance.
- Quality Management System (QMS) Development: Establish a robust QMS that aligns with GMP principles and ensures product quality throughout your organization.
- SOP Development and Review: Create and review standard operating procedures (SOPs) to guide your operations and ensure consistency.
- Regulatory Compliance: Stay up-to-date with the latest regulatory requirements and ensure your organization is in compliance with all relevant standards.
- Internal Audits: Conduct regular internal audits to assess your compliance with GMP and identify areas for improvement.
- Training and Education: Provide training and education to your staff on GMP principles and quality assurance best practices.
- Corrective and Preventive Actions (CAPA): Assist in the investigation, root cause analysis, and implementation of CAPAs to address quality issues.
- Documentation and Record-Keeping: Ensure that your documentation and record-keeping practices meet GMP requirements.
- PQR
- Vendor management
- Recall management
Why Choose Us:
- Deep Industry Expertise: Our team has extensive experience in the life sciences industry, providing in-depth knowledge and insights.
- Customized Solutions: We tailor our services to meet your specific needs and challenges.
- Proven Track Record: We have a successful history of helping clients achieve and maintain GMP compliance.
- Commitment to Quality: We are dedicated to delivering the highest quality services and ensuring your success.
Let us help you elevate your quality assurance and GMP compliance program. Contact us today to discuss your specific needs and learn how we can support your organization.
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.