FREYR AWARDED GLOBAL REGULATORY INTELLIGENCE SERVICES CONTRACT
Freyr Solutions, a global regulatory solutions and services company, has signed a regulatory service contract with a global consumer products company with a revenue base of $17.42bn; under which Freyr will provide strategic regulatory intelligence services.
FREYR BAGS STRATEGIC REGULATORY SERVICE CONTRACT WITH A GLOBAL SOUTH KOREAN PHARMA COMPANY
Freyr has won a regulatory services contract from a $674m global South Korean pharma client, another strategic win in the new globally emerging growth markets. Under the terms of the contract, Freyr will be engaged to embark on a suite of activities including end-to-end dossier management, publishing and submission of key active API’s (DMF) predominantly for the US market.
FREYR TO PROVIDE STRATEGIC REGULATORY INTELLIGENCE SERVICES FOR TOP-5 CONSUMER HEALTH COMPANY
Freyr has successfully designed a Regulatory Intelligence product version for a global Top 5 Multinational Pharmaceutical and Consumer Healthcare Company. Freyr’s Regulatory Intelligence solution will enable regulatory professionals working for large pharmaceutical companies to be up to date with the impact of new global requirements affecting the product lines that they are responsible for.
FREYR SELECTED TO PROVIDE CMC REGULATORY SERVICES FOR A GLOBAL PHARMA R&D FIRM
Riding on its core values of providing highest quality standards and delivery excellence across client engagements, Freyr has added yet another feather to its cap. Following the successful project delivery of an ongoing engagement, Freyr has signed another contract to provide strategic services in the CMC Regulatory Services space for an independent associated company providing Research & Development in three core areas of pain, oncology and respiratory.
Freyr launches FREYR UDI VISION – A three part webinar series
Freyr announces the launch of its FREYR UDI VISION – a three part webinar series that will provide an in-depth view and explain the intricacies and nuances of UDI submission process based on the real-time case scenarios, queries and challenges faced by medical device companies.
Freyr’s Specialized Regulatory Services for New Strategic Markets -Africa & Sub Sahara Countries
Freyr unveiled its suite of specialized regulatory services for new strategic markets that will cover Africa including the South Africa, Sub Saharan and North African regions like – South Africa, Ghana, Kenya, Nigeria, Angola, Uganda, Namibia, Zimbabwe, Zambia, Mauritius, Tanzania, Botswana and Malawi.
Freyr wins a UDI Compliance Project with BSD Medical Corp
Freyr has been chosen as a solution partner by BSD Medical Corp, a leading US-based medical device company, specializing in manufacturing hyperthermia systems for cancer treatment. Freyr will provide end-to-end UDI compliance solution and support for BSD Medical Corp to meet the fast approaching deadline for GUDID submissions.
Freyr launches Enterprise Cosmetic Regulatory Services for EAA, US and Asian Countries
Freyr announced the global launch of its full-services Enterprise Cosmetic Regulatory suite targeted to comprehensively cover countries in the EEA, US and Asian regions.
Freyr launches Freyr IDENTITY: The Accurate, Efficient and Faster UDI Compliance Solution
Freyr launches Freyr IDENTITY, the accurate, efficient and faster UDI compliance solution. Freyr IDENTITY is the latest addition to Freyr’s growing Regulatory Software Solutions portfolio and is aimed at enabling medical device companies successfully navigate through the UDI compliance landscape.
Freyr fuels its Global Growth Plans with a Major Facility Expansion.
Freyr completed the addition of a new 150 capacity facility to its Global Development & Operations Centre in India. As part of the global expansion plan, the new facility will complement Freyr’s strategic Business Acceleration Program that has recently won the company several global accounts with Top Pharma & Life Sciences companies.
The facility further increases Freyr’s Regulatory Workforce by over 20% and will serve as a strategic global delivery hub for Freyr’s Regulatory CoEs and R&D Services workforce that has been earmarked to globally deliver a wide range of services in the Regulatory Affairs, Regulatory Operations, Regulatory Intelligence and Regulatory Information Management areas.
Freyr wins a large project to provide Onsite Regulatory Services for a global Top 10 Fortune Pharma company.
Freyr has been engaged to provide strategic Onsite Regulatory Services for a Top 10 Global Pharmaceutical company based in the U.S. The project will broadly cover regulatory services for product development & maintenance, submissions, clinical trial authorizations, marketing authorizations, life cycle management etc.
Freyr selected by a global Top 20 Fortune Neutraceutical company to undertake a major eCTD Submission project.
Freyr has been selected for a large Regulatory Operations Project by a Global Top 20 Pharma/ Neutraceutical company to support eCTD Submissions Publishing services for an upcoming major submission. Freyr’s ten member, onsite team based out of client locations in US will support the project.
Freyr wins strategic partnership to provide complete Regulatory Submission Services for a global Generics Pharma company.
Freyr has been awarded a Regulatory Submissions project by one of the fastest growing Generic Pharmaceutical company based in Long Island, New York, US. The project will entail end-to-end services for regulatory submissions life cycle management to enable faster turnaround of regulatory approval timelines.
Freyr envisions a 20% increase in its Global Regulatory Affairs Workforce by Q2, 2014.
As part of a far reaching strategic business decision Freyrs has set into motion an aggressive plan to increase it’s Global Regulatory workforce by 20%.
The recruitment division of Freyr is embarking on creating a strategy to leverage traditional, online and third party channels to rapidly augment the headcount. A significant portion of resource fulfilment will focus on hiring top talent from the Regulatory Affairs domain.
Freyr also indicated scaling up its facilities and expanding it’s Global Development & Operations Center in India. The workforce increase is planned to coincide with Freyr’s facility expansion plans.
In Landmark Vote, EU Passes New Clinical Trial Regulation, Including Data Transparency Measures
The European Parliament (EP) today overwhelmingly passed new rules requiring pharmaceutical companies to make public the results of clinical trials, clearing the way for adoption of the rules in the EU later this year.
The 2 April 2014 vote saw approval of the new rules by a margin of 594 in favor to 17 against, with 13 members of parliament abstaining.
For more information visit www.raps.org
Freyr launches Freyr eTMF Lite – A low-cost, on-demand eTMF solution suite
20th March, 2014, New Jersey – Freyr today announced the global launch of a cloud-hosted, low cost and on-demand version of its Enterprise eTMF solution branded as ‘Freyr eTMF Lite’.
Freyr eTMF Lite, comprising of flexible, low-cost and high-value packs, is specifically designed to meet the unique and demanding TMF requirements of small-medium CROs as well as large fortune companies.
Positioned as best-in-class TMF solution, Freyr eTMF Lite is a 21 CFR Part 11 compliant solution based on the latest DIA TMF Model, to help companies efficiently manage their costly, complex and global trial document management needs across the entire lifecycle.
On the occasion, Ranvijay, VP Marketing, Freyr Solutions said, “Freyr is committed to innovate and offer Enterprise class benefits in a highly competitive and cost effective on-demand solution that will enable progressive companies to break-away from the traditional mold and become more agile, responsive and predictable in their compliance and regulatory obligations. Freyr’s soon-to-be-launched cloud solutions will be strategic value–added offerings for EVMPD, Labeling, Submission, Regulatory DMS, Product Registration, and Regulatory Information Management, including an exclusive Regulatory Intelligence Portal.”
Freyr eTMF Lite is one of Freyr’s first on-demand offerings available through Freyr’s Regulatory Cloud Portal with convenient subscription and payment options, which will include professional support and training packs.
For more information visit etmf.freyrinc.com
Freyr expands its hiring program in India.
Freyr expands its hiring campaign at its Global Operations & Development Center in India to onboard professionals from the regulatory and life sciences domains.
The campaign is expected to result in augmenting the support and development functions as part of Freyr’s readiness plans to complement its global expansion strategy. The augmented headcount will provide outsourcing support for U.S. as well as new geographies like LATAM, UK, EU and MEA.
Freyr attains a bona fide Minority Business Enterprise (MBE) status certified by NY & NJ Minority Supplier Development Council Inc. The inclusion as a NYNJMSDC member now makes Freyr as a nationally recognized business enterprise by major corporations, public agencies and non-profit organizations across the U.S.
The certification comes at the most opportune time as the company has re-aligned its business strategy and is all set with its major expansion plans within U.S. and strategic markets across LATAM, UK, EU and MEA.
For more information please visit – www.nynjmsdc.org
Freyr completes multiple successful Client Visits & Audits during CY 2013, ending the year with a high note, a year marked with transformational growth and success.
Freyr associates in Hyderabad and New Jersey had their Annual Celebrations, marking successful completion of several engagements and setting the stage for the new year. The Hyderabad Annual Event was conducted in one of the premium resorts (Leonia - http://www.leonia.in/)
Freyr Launches Green Earth Initiative on World Environment Day. An Eco-Volunteer team of 50+ Freyr associates undertook several environmental awareness initiatives including planting of trees, reducing plastic waste etc. Freyr’s Top Management team members replaced their gasoline cars with Hybrid cars, in an effort to reduce carbon emissions.
Freyr awarded multiple contracts in Regulatory Outsourcing (CMC, Change Control, Submission Publishing etc.), Scientific Information Management and Clinical & Regulatory Process Consulting services from Fortune 50 – Pharma, Consumer Healthcare major.
Freyr awarded ISO 9001 and ISO 27001 certification for its Quality Management System & Information Security Management System
Freyr expands its facilities in India & US: Freyr expanded its US operations in Cranbury, New Jersey by adding capacity in an all inclusive site with an on-premise Data Center, Corporate Offices & Business Continuity / Executive Work-space recovery capabilities
A Fortune 50, Top-3 Consumer Healthcare/ Pharma Company selects Freyr as a preferred partner for strategic Regulatory, Scientific Data Management & Safety services & solutions
Consumer Healthcare division of a New Jersey – US, headquartered Pharma major, selected Freyr as a preferred vendor to offer services and solutions for its global R&D group. The Pharma major is one of the Top 3 Global Pharma & Consumer Healthcare companies.
Freyr’s deep domain knowledge & operational strengths in Consulting, Operations Outsourcing & Technology Solutions in Regulatory/Scientific Information Management/Safety, helped in providing value to the Pharma giant in several key areas, i.e.: Cosmetic Safety Assessments, Technology Solutions & Strategy/Process consulting
Freyr launches Freyr eTMF and Freyr Regulatory DMS Software
Freyr launched two key products as a part of its regulatory/clinical information management portfolio – Freyr Regulatory DMS & Freyr eTMF. Freyr Document Management System (DMS), is built ground up for Regulatory document management needs. It is a meta-data driven, highly configurable Web-based product, which is extremely easy to use. Freyr eTMF (Electronic Trial Master File) is based on Freyr DMS framework and is an out of the box TMF system with pre-configured Folder structures and a rich meta-data repository. More information on our products can be found
Freyr offers industry leading EVMPD Software and Services. A Top 20 EU Pharma major selects Freyr as its enterprise EVMPD platform