Consultancy Program at Setax: Enhancing GxP Compliance and Quality in Pharmaceutical Distribution
The Setax Consultancy Program delivers tailored solutions to help pharmaceutical companies meet the highest industry standards. Whether you seek guidance in Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), or Quality Management Systems (QMS), Setax streamlines operations and ensures regulatory compliance through expert-driven consultancy.
Our program starts by assessing your current processes to identify compliance gaps. We work closely with your team to develop customized solutions, providing hands-on support to ensure seamless implementation and optimized operations. Additionally, we build long-term improvement strategies to ensure continuous success.
Identification of issues with your pharmaceutical quality system to compliance to Good Distribution Practice.
At Setax, we have worked with companies including GlaxoSmithKline, Roche, and Celltech.
We are seasoned experts in the Quality Management System Environment and continue to share our knowledge with clients.
Our Consultancy Programmes
Create a detailed project plan with defined milestones to ensure your key deliverables are captured, tracked, and achieved.
Outsource your Responsible Person duties to ensure compliance with GDP requirements and regulatory standards, maintaining operational integrity.
Conduct a comprehensive gap analysis of your Quality Management System (QMS) to ensure it aligns with Good Distribution Practice Standards and regulations.
Get expert guidance and support in obtaining GxP licenses and GxP compliance, including Good Distribution Practice certification/ wholesale Dealers Authorisation (WDA) ensuring full compliance with regulatory requirements for Good Practice certifications.
Receive tailored assistance to prepare for regulatory inspections, ensuring your business is fully compliant and ready to meet all inspection requirements.
What You’ll Get: GxP Compliance
Our consultants provide your organization with a functional and compliant pharmaceutical quality management system that aligns with your business strategy. They stay up to date with current GxP regulations by attending the annual MHRA GMDP Conferences and participating in various QA forums on LinkedIn. We apply project management principles and tools to manage your projects effectively, ensuring smooth implementation and success.