Regulatory Consultations
Regulatory Consultations
About Regulatory consultations
At PharmaPure, we provide comprehensive Regulatory and Quality services to ensure your pharmaceutical products meet the highest global standards. From preparing Non-Conformity Reports (NCRs) and supporting corrective actions, to thorough Drug Master File (DMF) reviews and effective responses to regulatory inquiries, we help streamline your compliance processes. Our experts also assist in building robust, GMP/GLP/GCP-compliant Quality Systems tailored to your needs. With our guidance, you can confidently navigate regulatory challenges, maintain product integrity, and accelerate approvals.
Authority Deficiency and Inquiry Response
Minimize regulatory setbacks with our Authority Deficiency and Inquiry Response support. We assist in addressing queries, deficiencies, and requests from regulatory agencies, ensuring timely and compliant responses. Our structured approach helps resolve issues efficiently, keeping your submissions on track for approval.
DMF (Drug Master File) Review and Evaluation
Streamline your regulatory submissions with our DMF Review and Evaluation services. Our experts assess your Drug Master Files for accuracy, completeness, and compliance with FDA, EMA, and other global regulatory requirements. We ensure your DMFs meet stringent standards, reducing delays in approvals and facilitating smoother interactions with health authorities.
Quality System Establishment
Build a robust and compliant Quality System tailored to your organization’s needs. We guide you in implementing GMP, GLP, and GCP frameworks, developing SOPs, and establishing quality management systems (QMS) that align with FDA, EMA, and ICH guidelines. Our services ensure your operations meet regulatory expectations while enhancing efficiency and product quality.
Non-Conformity Report and Results Consultation
Ensure compliance and continuous improvement with our expert Non-Conformity Report (NCR) and Results Consultation services. We help you identify, document, and address deviations effectively, providing actionable insights to resolve issues and prevent recurrence. Our team supports you in regulatory submissions, corrective actions (CAPA), and audit responses to maintain compliance with global standards.