Regulatory Compliance Services in Ahmedabad

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.