New Jersey – June 04, 2019: Freyr, a leading global Regulatory solutions and services company, has announced the launch of Freyr SPL – a dedicated platform to streamline structured product labeling (SPL) submissions. Freyr SPL streamlines complete activities from initiation to submission-ready SPL package creation. Freyr SPL is built ground-up aligning with the United States Food and Drug Administration (USFDA) Regulatory requirements and compliance standards; 21 CFR Part 11 criteria and Health Level Seven (HL7).
Freyr SPL helps pharma, biotech companies convert their product information leaflets into Extensible Mark-up Language (XML) format i.e., SPL format, to be submitted to United States Food and Drug Administration (US FDA).
Freyr SPL offers a robust platform to create, validate and store submission-ready information in SPL format for various types of documents, as mandated by FDA. Freyr SPL is offered as on-cloud and on-premise models integrated with enhanced features such as electronic record management and electronic signatures to ensure security and reliability.
To support applicants, streamline their SPL submissions, Freyr SPL is designed with unique features such as:
- SPL Initiation
- SPL Authoring
- SPL Validation
- SPL Review
- SPL Versioning
- SPL Approval
- SPL Status Track
“With a comprehensive understanding of compliance standards, Freyr has assisted numerous clients in successful SPL submissions compilations. Leveraging expertise gained from SPL services and clear analysis on industry’s technology requirements for SPL, Freyr has developed Freyr SPL to reduce manual efforts in collating, validating, authoring, reviewing and converting SPL submissions,” said Suren Dheenadayalan, CEO, Freyr. “The launch of Freyr SPL is another step forward in Freyr’s technological advancements aimed at empowering organizations in scaling up and streamlining their Regulatory operations,” added Suren.
Freyr is a leading, niche, full-service global Regulatory Solutions and Services Company supporting, Large, Medium and Small Size Global Life sciences companies, (Pharmaceutical |Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics) in their entire Regulatory value-chain; ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions etc. to Post- Approval / Legacy Product Maintenance, Labeling, Artwork Change Management and other related functions.
Headquartered in New Jersey, USA, Freyr has regional offices across UK, Germany, UAE, Canada, Mexico, Singapore, Malaysia, South Africa, Slovenia, Austria, Sri Lanka and has Global Delivery Center in Hyderabad, India.
- 300+ global clients and growing
- 600+ global Regulatory experts
- 700+ regional Regulatory affiliates across 120+ countries
- ISO 9001 Certified for strong process and quality management
- ISO 27001 Certified for information security management, state-of-the-art infrastructure