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.

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End-to-end Compliance Services - Overview

Freyr is flexible and attentive to client-specific needs in providing quality compliance consulting. Its proven expertise in audit and compliance services and specialization in Regulatory and cutting-edge technology can establish a centralized, cost-effective, high-quality, and end-to-end audit and compliance services proposition for an organization’s compliance assurance.

Freyr provides quality compliance services and aims to set up an audit and compliance services framework for implementing a system (GxP) that can be tailored to fit the specific 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.

Quality Compliance Services

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, 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.
  • 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.

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