Regulatory Compliance Service
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At ARIZONA, our compliance consultants have a strong working knowledge of requirements and can help implement the necessary quality systems to meet the regulations. Additionally, we have substantial experience helping clients with remediation when their quality systems implementation and management fall short of meeting regulatory requirements. We provide GMP consulting to proactively help our clients avoid issues with regulatory agencies. GMP consulting is often performed by a gap assessment of the current quality systems and determining if there are any observations that expose them to enhanced regulatory scrutiny. ARIZONA then provides recommendations for remediation and will provide hands-on support with the implementation of remediation activities, as necessary. We also provide a set of solutions unique to regulatory challenges faced by compounding pharmacies, including qualification and validation, response and remediation support like FDA 483s, warning letters, Drug Quality and Security Act (DQSA) assessment, compliance audits for USP and cGMP training. ARIZONA compliance services augment our clients’ internal capabilities to prepare for, execute and address compliance-related observations and deficiencies, thus mitigating our clients’ regulatory risk.
Environmental Consulting & Compliance Management Service
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Environmental Consulting & Compliance Management Consent to Establish (CTE. NOC) & Consolidated Consent & Authorization (CCA.CTO) CIE Product Mix Change application. CC&A Renewal. CTE & CCA Amendment CGWA Application Revocation Application of Closure Order Application for Name Change. Correction in Consents GPCB Approval for Hotels and Hospitals Authorization under Plastic Waste Management Rule, Biomedical Waste. Batteries, and other Waste Management Rules Extended Producer Responsibility (ERR) Registration under Plastic Waste. Batteries, Waste Tyre, and Used OR, ERR Target Compliance. filing Annual and Quarterly returns Soil & Hydro Geology study & remediation work Rule - 9 Application & registration for importing and Recycling of hazardous waste Environmental Management System ETP, MEE. RO Adequacy and Efficiency Report Non-Applicability of EIA. No increase in pollution load and other type of Report Preparation Environmental Clearance EC, Environmental Impact Assessment Form - A and Form - 5. Monthly and Yearly Patrak, EC Compliance etc. Notice Reply. Handling of XGN, Porivesh and other tools given by PCB Legal advice on the matter related to environment acts & its implication
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