Princeton, NJ - October 29, 2020: Freyr solutions, a leading global Regulatory solutions and services provider announces successful completion of its first Structured Product Monograph (SPM) submission to Health Canada (HC). The submission is said to be one of the early pilot sample XMLs received by HC. Freyr collaborated with HC to work on the finalized SPM included in their eCTD submission. With the submission, Freyr has become one of the first few companies to submit SPM to HC.
In brief, on receiving the scope of SPM from HC in relation to controlled vocabularies, implementation guide and stylesheets, Freyr has compiled and submitted the pilot SPM project to Health Canada during Phase1 evaluation. Following the submission, Freyr has received an error-free validation for submission from Health Canada. Post the SPM pilot submission through 2016 Standard Template, designated stakeholders from Freyr attended the live meeting with Health Canada. During the discussion with Health Canada, stakeholders have proposed to modify the validation logic and suggested to include few controlled vocabularies in packaging component.
“We are very happy for our contributions to implement some key validations that were updated in Health Canada validation system. Communicating with Health Canada early on, has given Freyr the advantage to participate in informative sessions and discussions regarding the guidelines,” said Suren Dheenadayalan, Co-CEO, Freyr. “Basis the key takeaways from the discussion with Health Canada, we have now firmly created a solution for organizations grappling with SPM challenges – a web-based tool - Freyr SPL/SPM that automates compliance with current SPM format rules using unique step SPM conversion methodologies,” added Suren.
About Freyr
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 | Chemicals) 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 ha s Global Delivery Center in Hyderabad, India.
- 600+ global clients and growing
- 800+ global Regulatory experts
- 800+ 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