,End-to-end Regulatory Compliance Services - Overview
Freyr understands client-specific needs and provides quality compliance consulting. Its proven expertise in end-to-end Regulatory compliance services and specialization in Regulatory and innovative technology can establish a centralized, cost-effective, high-quality, and end-to-end audit and compliance services proposition for an organization’s compliance assurance.
We provide quality compliance services and aim to set up an audit and compliance services framework for implementing a system (GxP) that can be tailored to fit the environment, considering the scope of operations, the complexity of processes, and the appropriate use of finite resources per the client's SOPs, recommended standards, and compliance guidelines.
End-to-end Regulatory Compliance Services
Freyr’s 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 of the USFDA, EU, MHLW, ICH-GCP, 21 CFR Part 11, PIC/S, GAMP 5, HIPAA, CSV standards, data transfer content standards, ISO 27001, and 9001 standards | 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 SDLC quality compliance services: Process audits, information security audits, documentation audits, SDLC audits, SDLC control 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; | Remote |
Software Validation (Computer System Validation) for Waterfall and Sprint SDLC | 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.
Freyr’s 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
By leveraging our end-to-end Regulatory compliance services, clients in the life sciences sector can achieve and maintain compliance, streamline their Regulatory workflows through advanced life sciences compliance software, and stay ahead of evolving Regulatory expectations with robust strategies.
