Quality Services
Quality & Compliance
We at ND Global understand that the path of Pharma Quality Assurance is different from medical devices, and that’s why we have a dedicated team to drug quality assurance. We possess extensive expertise in the realm of Quality Assurance. Our team of QA consultants is highly specialized in Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP), focusing on importation and batch release. Additionally, we possess an in-depth and comprehensive understanding of the relevant legislative frameworks for country-specific regulations.
Remediation
ND Global can provide invaluable assistance in navigating the multi-faceted process of remediation, which is structured into three distinct phases: Characterization, Decontamination, and Clearance. It’s important to note that the dynamic nature of response efforts might cause these phases to overlap or even unfold concurrently. ND Global’s expertise and support can be instrumental in each of these phases.
Audit
ND Global is well-equipped to provide comprehensive support and expertise in conducting quality audits for pharmaceutical companies. Their involvement can play a pivotal role in assessing and enhancing your company’s quality assurance and control programs.
ND Global can provide invaluable assistance in navigating the multi-faceted process of remediation, which is structured into three distinct phases: Characterization, Decontamination, and Clearance. It's important to note that the dynamic nature of response efforts might cause these phases to overlap or even unfold concurrently. ND Global's expertise and support can be instrumental in each step.
ND Global addresses data integrity challenges in healthcare, aligning electronic records with stringent regulatory guidelines set by authorities such as FDA, EMA, MHRA, PIC/S, and WHO. Through modernizing data practices, refining policies, and applying ALCOA + principles, they mitigate risks and ensure patient safety while maintaining compliance with evolving industry standards.
ND Global specifies enhancing modern quality systems by providing expertise in investigating manufacturing, testing, and distribution discrepancies and addressing product complaints. With a firm understanding of Good Manufacturing Practice (GMP) regulations and industry guidance, our experienced team emphasizes structured investigations to determine root causes. This process facilitates practical corrective and preventative actions (CAPA), ensuring continuous improvement. We have delivered numerous investigation reports with over 30 years of experience, accommodating small and large teams. Our diverse Subject Matter Experts (SMEs) contribute to complex discrepancy and complaint management, seamlessly integrating with your team to offer investigation, root cause analysis, and CAPA support within your existing quality system or by developing optimized programs. Drawing from extensive consulting and operational management roles, we are well-equipped to strengthen investigation, root cause determination, and CAPA systems to meet regulatory standards.
ND Global specializes in designing, constructing, and overseeing Quality Management Systems (QMS) for pharmaceutical, biotech, API formulations, Nutraceuticals, and medical device manufacturers. Our seasoned experts comprehend intricate regulatory aspects and compliance systems crucial for operational success. We guide your team through tailored regulatory processes, ensuring a robust QMS that achieves continuous improvement, meets regulatory requisites, and establishes streamlined processes aligned with your organization's phase and scope. As a trusted partner, we pave the way for compliant and efficient operations in ever-evolving business landscapes.
ND Global is well-equipped to provide comprehensive support and expertise in conducting quality audits for pharmaceutical companies. Their involvement can be pivotal in assessing and enhancing your company's quality assurance and control programs.
