Overview

Freyr offers several Regulatory Affairs and Regulatory Operations functions in an Offshore-based model from our Global Regulatory Operations Center in Hyderabad, India.

Freyr is able to offer cost-savings of 60% and upwards on key Regulatory Affairs and Operations functions that are done out of our Hyderabad facility. Many of the Regulatory Affairs functions being offered are first-of-its kind and Freyr is pioneering innovative models of offering offshore-based Regulatory services.

 

Hybrid, Global Delivery Model

Hybrid, Global Delivery Model

Freyr has extensive capabilities to deliver Regulatory projects and Operational supporting engagements in flexible models that suit our clients’ needs and budgets. Many of our engagements are delivered with the right combination of Onsite and Offshore services. We constantly assess the risk / return parameters of key Regulatory functions that can be done Offshore.

Our Global Regulatory Affiliate teams work in conjunction with our Offshore-based Regulatory teams to offer significant value to our clients - the right combination of local support and cost-benefits of offshore-based services. Freyr’s offshore-based Regulatory experts also travel globally on several key engagements.

Localization Activities

  • Health Authority Interactions
  • Product / Market specific Scientific Content Creation including Language Translations
  • M1- Market specific legal and administrative documentation

Centralization / Support Activities

  • Global Submissions Publishing
  • M2-M5 Dossier Preparation
  • CMC Change Control Management
  • Artwork Management Regulatory Information (Data and Documents) Management
  • Regulatory Intelligence
  • Compliance Monitoring and Business Risk Management

Onsite Consulting

Onsite Consulting

Freyr has a vast Global Regulatory Affiliate Network that enables smooth execution of Regulatory projects onsite while offering a diverse set of skill-sets across Global Regions, including, North America, EU, Asia – Pacific, Africa, CIS Countries.

Freyr’s Regulatory Resource Expertise Spread

  • Regulatory Affairs Experts (focused on Therapeutic areas and specific Health Authorities)
  • Regulatory Process Consultants
  • Regulatory Information Management Experts
  • Submission Publishers
  • Labeling & Artwork Management Resources
  • Global Regulatory Program Managers
  • Toxicologists, Chemists & Scientists
  • Validation, IT – CSV, QA, Resources
  • Clinical Data Management, CDISC & CRA resources
  • GxP Audit experts
  • Other Regulatory, Clinical, QA, IT and R&D resources

Regulatory Software Support

Regulatory Software Support Services

Freyr has a large pool of Software & Systems Engineers who provide support and maintenance services for 3rd party Regulatory and R&D Software systems.

Freyr resources have experience across a diverse set of Regulatory Submissions software and can offer highly cost-effective Offshore-based or Onsite support / maintenance of Regulatory & Compliance related software applications.

  • Submissions Planning Tools - Ocatgon ViewPoint, Documentum, SharePoint, LiveLink & other custom-applications
  • Assembly & Publishing Tools - Liquent Insight Publisher, Lorenz Docubridge, ISI Publisher, eCTD Express, ViewPoint, Adobe Acrobat
  • Validation Tools - Lorenz eValidator, EURS Validator, Belgium NeeS Checker
  • Review Tools - Rosetta Phoenix
  • Archiving Tools - Customer specific archiving tools

* Software names and software are registered trade mark and property of the respective companies that own the Intellectual Property / Software.

Regulatory Program Management & QA

Regulatory Program Management & QA

In any of its delivery models outlined, Freyr follows 2 key foundations as a part of its best-practices approach:

  1. Project Management Office & Delivery Oversight
  2. Quality Management, Metrics and KPI

Freyr PMO and Delivery Oversight functions are integral to ALL the Regulatory projects and technology engagements. The PMO group enables the following key objectives and activities:

Strategically Aligned PMO

  • Functional Stewardship
  • Compliance and Quality Adherence Metrics
  • Efficient Resource Deployment and Utilization
  • Contingency Planning & Risk Management
  • Process Maturity Metrics
  • Stakeholder Alignment and Winning Operating Models
  • Closely Monitored Cost-Benefit Realization

Quality Management, Metrics and KPI

Freyr is ISO 9001:2008 & ISO 27001:2013 certified and has an independent QA Group overseeing Quality aspects of all engagements.

Click here to download Freyr’s Program Management and QA KPI’s.

 

100% Quality Deliverable in Strict Timelines with Global Labeling Management

Freyr Established Tracker to provide global CCDS status and centralizing the process providing visibility to all the local operating companies.
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CLIENT TESTIMONIALS

 
  • I highly recommend Freyr for any of your special needs. They have assisted my company with multiple submissions. They have kept to the established timelines each time and kept working to make sure we got the submission correct and in the shortest amount of time.

    – CEO, J.A.R. Labsy

  • This has been a large team effort and the continued progress is appreciated. Many thanks to the Freyr team as they were integral over the last few months in helping to reach a critical project milestone. Excellent team work!!

    – Program Manager, Global Top 5, $70+ Bn, Pharma & Consumer Healthcare Company