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End-to-end Regulatory Compliance Services
Pharma wizard offers tailored compliance consulting, leveraging expertise in Regulatory Affairs and technology to establish centralized, cost-effective audit services. With a focus on client-specific needs, we ensure quality and compliance services aligned with SOPs and industry standards.
End-to-end Regulatory Compliance Services - Overview
Pharma Wizard understands the unique needs of each client and delivers high-quality compliance consulting. With proven expertise in comprehensive regulatory compliance services and a strong focus on regulatory excellence and innovative technology, we can help establish a centralized, cost-effective, and high-quality audit and compliance framework to strengthen an organization’s compliance assurance.
Our goal is to provide tailored compliance solutions by designing and implementing an adaptable GxP audit and compliance framework. This system is customized to align with the client’s operational scope, process complexity, and resource availability, while adhering to their SOPs, recommended standards, and relevant compliance guidelines.
End-to-end Regulatory Compliance Services
- Expertise
- Advantages
Pharma wizard end-to-end Regulatory compliance services are supported by a dedicated team of compliance experts who specialize in quality and compliance services for the life sciences industry. We provide Regulatory compliance services that are scalable, adaptable, and focused on delivering measurable results.
| Audit and Regulatory Compliance Services | Place of Activities – Cost-effective Hybrid |
|---|---|
| Managing quality, Regulatory, and information security at the organization level (process and QMS documents) | Remote |
| Providing quality compliance services and ensuring compliance with applicable guidelines and legislations as per the authority needs. | Remote |
| Standard Operating Procedures (SOPs) preparation, review, and change management | Remote |
| Training coordination and documentation | Remote |
| Hosting Regulatory compliance audit: On-site compliance auditing, web audits, supporting Regulatory audits, certification audits, and accreditation audits | Remote: If < 6 audits per year Nearshore: 6–8 audits per year On-premises: ≥ 12 audits per year |
| Conducting internal audits for quality compliance services: Process audits, information security audits, documentation audits, inspections, and mock audits | Remote / On-premises |
| Conducting Management Review Committee (MRC) meetings, minutes, and follow-up | Remote |
| Supplier Audits: Audits on outsourcing (resources as well as processes outsourcing) | On-premises |
| CAPA Management: Plans CAPA, triages CARs, and performs RCA; alerts senior management on non-compliance concerns that pose a significant risk | Remote |
| Software Validation (Computer System Validation) | Remote |
| Maintaining awareness of updates in the changing Regulatory landscape that impact GxP by establishing and retaining relations with external agencies as relevant to business | Remote |
| Assist business development/sales by responding to RFIs and RFPs | Remote |
| Review customer feedback forms | Remote |
| Quantification of departmental deliverables and presentation of metrics to the management regularly – Management System Metrics Dashboard | Remote |
| Drive/Coordinate continual improvement programs | Remote |
Our comprehensive Regulatory compliance services portfolio includes Regulatory compliance audits and the implementation of compliance guidelines that meet the highest industry standards.
Pharma wizard commitment to end-to-end Regulatory compliance ensures that clients benefit from a single, integrated solution to manage all aspects of Regulatory compliance, from documentation and training to audit readiness and ongoing improvement.
Pharma wizard commitment to end-to-end Regulatory compliance ensures that clients benefit from a single, integrated solution to manage all aspects of Regulatory compliance, from documentation and training to audit readiness and ongoing improvement.
- Science-based approaches
- Make decisions based on the understanding of the intended use of a product
- Proper identification and control of areas of potential process weakness
- Responsive deviation and investigation systems that lead to timely remediation
- Sound methods for assessing and reducing risk on audit and compliance services
- Well-defined processes and products, starting from development and extending throughout the product lifecycle
- Quality and compliance consulting services
