End-to-end Compliance Services

Freyr 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 compliance frameworks aligned with SOPs and industry standards

End-to-end Compliance Services - Overview

Freyr understands client-specific needs and provides quality compliance consulting. Its proven expertise in audit and 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.

Audit and 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; alerts senior management on non-compliance concerns that pose a significant risk	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

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