Freyr's Integrated Regulatory Management System Framework
Freyr Certifications
ISO 13485 : 2016
Provision of Global Consulting Services Applicable to the Medical Device and In Vitro Diagnostic (IVD) Industry for
Scope of Certification
- Product Registrations
- Regulatory Affairs
- Clinical & Medical Writing
- Quality Management System
- Labelling & Artwork Services
- Authorized Representation Services such as:
- a. EAR
- b. Swiss Rep
- c. UKRP
ISO 27001 : 2013
Information Security Management Services cover the Software and Regulatory Services of the following departments
Scope of Certification
- Product (Software) Development and SaaS
- Global Labeling Management
- Regulatory Artwork Management
- Regulatory Publishing
- Dossier Management and Chemistry Manufacturing and Controls (CMC)
- Regulatory Intelligence
- Regulatory Information Management
- Cosmetic Compliance
- Safety Assessment
- Medical Writing
- Global Regulatory Services
- Good Pharmacovigilance Practice (GPvP)
*Statement of Applicability SOA Version 9.0 dated 09.02.2022.
Scope of Certification
- Product (Software) Development and SaaS
- Global Labeling Management
- Regulatory Artwork Management
- Regulatory Publishing
- Dossier Management and Chemistry Manufacturing and Controls (CMC)
- Regulatory Intelligence
- Regulatory Information Management
- Cosmetic Compliance
- Safety Assessment
- Medical Writing
- Global Regulatory Services
- Good Pharmacovigilance Practice (GPvP)
Quality Management System covers the following departments
FREYR* is committed to meet and exceed customer expectations by providing high quality, costeffective, 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 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*: - Freyr Software Services Pvt. Ltd. and it's subsidiary companies.
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 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 ensuring the same at all times.
This policy will be regularly reviewed, updated as necessary, applied and communicated to all the employees and persons working for or on behalf of Freyr and made available to interested parties and the public.
Freyr* : Freyr Software Services Pvt Ltd. and it’s subsidiary companies.