New Jersey – 19 December 2018: Freyr, a leading global Regulatory solutions and services company, has announced the release of Freyr SUBMIT PRO – an upgraded version to its existing in-house eCTD publishing and submission tool, Freyr SUBMIT. The latest version is built with advanced web-based platform, offers better cloud support, and is capable of seamless integration with multiple DMS platforms like Open Text, SAP DMS etc.
Keeping in view of industry’s specific requirements, i.e. one-stop submission tool for global switchovers, Freyr SUBMIT PRO is designed with an additional focus on regional submission templates of the US FDA, EMA, Health Canada, TGA and other major global health authorities. The advanced version is better enabled to support users right from eCTD submission preparation, submissions to HA query management.
Being 21 CFR part 11 compliant, the SUBMIT PRO has all features of its predecessor, Freyr SUBMIT and along with many advanced features that are listed below.
- Inbuilt Validator
- Submission tracking
- Health authority query management
- Integration with Leading EDMS.
- Collaborative submissions preparation & review
- Inbuilt eCTD viewer
- Inbuilt pdf manager
- Import Utility
- Module cloning
- Cross Reference
“With a proven expertise of handling 50,000+ submissions to global health authorities across 30+ countries, we have got an opportunity to learn what exactly the Freyr SUBMIT’s customers are looking for. Having worked upon those critical observations, we have ensured that the updated version Freyr SUBMIT PRO is nothing less than what they needed. The updated tool, being user-friendly, aims to help the users go for the submissions in quick TATs, as ever” said, Suren Dheenadayalan, CEO, Freyr. “Our focus in the future will remain targeted towards eliminating the challenges while using technology in the Regulatory landscape of life sciences,” 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