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Good Manufacturing Practice (GMP) compliance is a critical element in ensuring the safety, efficacy, and quality of pharmaceutical and biotechnology products. With stringent global regulatory standards, maintaining GMP compliance is essential for businesses aiming to achieve market access and meet quality expectations.
DDReg offers a comprehensive range of GMP compliance services designed to support your regulatory journey, from initial vendor qualification to post-market monitoring. Our team of experienced GMP consultants provides expert advice and practical solutions to help clients navigate the complex regulatory environment.
Expertise and Knowledge
Our GMP consultants possess extensive knowledge of GMP regulations, cGMP compliance with EUGMP/US FDA/Saudi FDA/ PIC/s/ WHO GMP and other global industry standards. We stay up-to-date with regulatory changes and provide expert guidance to ensure your operations meet both local and global GMP requirements.
Customized Solutions
We understand that each manufacturing industry including API, Intermediates, Excipients, Formulation etc. has unique needs. Our GMP services are tailored to provide solutions that are specifically designed to meet the regulatory requirements of your pharmaceutical industry.
Comprehensive Support
From initial assessments to ongoing compliance monitoring, we offer end-to-end GMP compliance support. Our team is committed to providing continuous assistance, ensuring that your operations remain compliant throughout the product lifecycle.
Streamlined Regulatory Processes
Our goal is to simplify the regulatory journey for you. We provide practical solutions to help you navigate the complexities of GMP compliance, making the process more manageable and less time-consuming.
GMP Vendor Qualification
GMP & QMS Gap Analysis
GMP Inspection Support
GMP Consulting and Training
Auditee Support
Internal GMP Audits
Mock Inspections
QMS Building / Revision
Maintenance GMP Vendor Audit
GMP Desktop / Checklist Assessments
Is your Quality Management System (QMS) aligned with GMP requirements?
Have you qualified all your vendors according to GMP standards?
Do you conduct regular internal GMP audits and mock inspections?
Are you prepared for external GMP inspections?
Is your team adequately trained in GMP regulations and processes?
Are your processes continuously monitored for compliance?
At DDReg, we are committed to helping you achieve and maintain GMP standards. With our experienced consultants and comprehensive range of GMP services, we ensure that your operations meet the highest regulatory standards, reducing risks, improving product quality, and ensuring market success. Whether you are looking to meet FDA, EMA, or other regulatory requirements, our GMP services are tailored to meet the unique needs of your manufacturing processes and quality management systems.