Freyr's Integrated Regulatory Management System (IRMS) Framework 

Freyr's Integrated Regulatory Management System (IRMS) Framework

Freyr Certifications

ISO 9001: 2008
Quality Management System

ISO 27001 :2013
Information Security Management System

Scope of Certification

  • Software Development
  • Global Regulatory Services
  • Regulatory Publishing
  • Chemistry Manufacturing and Controls (CMC)
  • Regulatory Intelligence
  • Electronic Trial Master File (eTMF)
  • Global Activity Tracking Tool (GATT) 
  • Learning Management System (LMS)
  • Regulatory Information Management
  • Cosmetic Compliance
  • Cosmetic Safety Assessment
  • Global Labelling Management
  • Dossier Management
  • Pharmacovigilance and Safety

Freyr Quality Policy

Freyr is committed to meet and exceed customer expectations by providing high quality, cost effective, secure and reliable software development and regulatory services for complete customer satisfaction and passion for service excellence.

This is achieved through:

  • Applying Risk based methodology
  • Continual Improvement in our processes and systems that can further help in adapting to the rapidly changing technological environment
  • Achieving Quality by Design
  • Enhancing competencies of personnel
  • Complying with applicable contractual, statutory, regulatory and legal requirements

All the employees of Freyr will understand, nurture and uphold the policies of the organization at all times.

This policy will be regularly reviewed, updated as necessary, applied and communicated to all employees, persons working for or on behalf of Freyr and made available to interested parties and the public.

Freyr Information Security Policy

Freyr is committed to ensure the Confidentiality, Integrity, and Availability of information and assets of clients, all the stakeholders and interested parties by adopting a formal Risk Management Framework and establishing an Information Security Management System that is improved on a continual basis. Information is protected from various security threats whether internal or external, deliberate or accidental.

Freyr’s Information Security Management System is aligned to business objectives, and ensures business continuity requirements; applicable contractual, statutory, regulatory and legal requirements of our business environment are complied with.

Information Security is the responsibility of Management, Business Managers, System Owners, IT Personnel and all employees of Freyr and Management is committed to ensure the same at all times.

This policy will be regularly reviewed, updated as necessary, applied and communicated to all employees and persons working for or on behalf of Freyr and made available to interested parties and the public.