cgmp consultancy services for Drug manufacturers and labs

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At Pluton cGMP Consultancy, we are committed to ensuring your pharmaceutical manufacturing processes meet the highest standards of quality and compliance. With our extensive experience in Good Manufacturing Practices (GMP), we provide expert guidance to help you navigate the complex regulatory landscape and achieve operational excellence.

Our team of consultants has over 18 years of experience in the pharmaceutical sector in the U.S. and Ethiopia. Our experts include former United States Food and Drug Administration (USFDA) Drug Specialists who have inspected manufacturing facilities of the world's largest drug manufacturers. The team has in-depth expertise in auditing sites that manufacture a variety of dosage forms, including sterile and biotech manufacturing facilities.

 Our Services:

• Comprehensive internal audits to identify compliance gaps.
• Preparation and support for regulatory inspections.
• Detailed audit reports with actionable recommendations.

• Development and implementation of robust quality management systems.
• Continuous improvement programs to enhance operational efficiency.
• Training for staff on quality management principles and practices 

• Guidance on local and international regulatory requirements.
• Assistance with regulatory submissions and documentation.
• Risk management strategies to ensure ongoing compliance.

• Support in process design, qualification, and validation.
• Documentation and protocols for process validation activities.
• Troubleshooting and optimization of manufacturing processes.

• Customized training programs on GMP and related topics.
• Workshops and seminars conducted by industry experts.
• Continuous professional development for your team.

• Expertise: Our team comprises seasoned professionals with deep knowledge of GMP and      regulatory requirements.
• Customized Solutions: We tailor our services to meet your specific needs and operational goals.
• Proven Track Record: We have successfully helped numerous clients achieve compliance and improve their manufacturing processes.
• Continuous Support: We provide ongoing support to ensure your continued success and compliance.