FREYR: A Specialist, Providing Regulatory Consulting, Operations & Technology Services

An ISO 9001:2008 & ISO 27001:2013 Certified Company, Freyr focuses on the entire Regulatory value chain of Bio-Pharma (Innovators / Generics), Consumer Healthcare and Medical Device companies, globally

Headquartered in New Jersey, US, Freyr was founded with an aim to exclusively focus on the entire regulatory value-chain to offer end-to-end Regulatory-Consulting, Software & Operations Outsourcing & Intelligence Services that help transform the way organizations meet their challenging regulatory requirements through strategy, innovation, creativity and technology. As a trusted advisor and partner to 6 of the Global Top 10 Pharma and Healthcare giants, Freyr has the direct visibility into the key regulatory concerns and challenges, technological drivers and regulatory market factors influencing the global pharma industry’s profitability and new-market-entry strategies.

Incorporated in 2011, the idea of Freyr was born out of the gaps in innovative and high quality regulatory solutions and services available versus the increasing demand from the Pharma industry seeking creative global partners to manage and support complex regulatory compliance program life-cycles and technology solutions. Freyr started off by leveraging its deep industry insights and integrated breadth of regulatory capability expertise to innovate and offer solutions and services that enabled transformation for clients across their complex Regulatory functions like CMC, New MA Dossier Preparation, Labeling& Artwork, Regulatory Submissions & Publishing, etc.

The company is a trusted partner providing end-to-end multi-geo, multi-lingual Regulatory services across Top 50 global brands for 6 of the Global Top 10, Top 20 Fortune 500 and many fast growing Small/ Medium Pharma, Consumer Healthcare and Life Sciences companies, including Sponsor and CRO companies. Freyr has pioneered specialized Centres of Excellence (CoEs) exclusively focusing on the entire Regulatory value-chain which are supported by rapidly growing global teams of 350+ Regulatory Professionals.

Leveraging its healthcare domain expertise and technology innovations, the company is evolving high end next generation regulatory solutions and services that are constantly driving accelerated performance, operations excellence and significant reduced cost of compliance benefits for clients.

Making foothold in the global map, Freyr holds Regulatory Operations Center at New Jersey in the US, Client Delivery Centre at Maidenhead in the UK and Global Delivery Center at Hyderabad in India.

Adding Value to the Customer based Environment

Innovative Software Solutions and Managed Service Offerings- Freyr designed innovative software solutions and managed service offerings to help clients leverage technology and new sourcing models to optimize and effectively navigate the complex regulatory landscape. Delivered on a global scale, over the years, the company’s offerings have helped clients to streamline, enhance and grow their regulatory functions, significantly save on operating and compliance costs and deploy superior strategies for their new product launch and new market expansion initiatives.

Flexible Engagement Models- Freyr offers flexible engagement models to clients that are customized to perfectly meet their unique needs. For its services engagement, it offers the options of Time and Material, Fixed, Project-specific, FTE-based, and Hybrid models. For its software solutions, the company offers engagement models based on Perpetual Enterprise License fee or a monthly Cloud SaaS fee.

One Stop Shop- Unlike competitors who either offer Product Solutions or Services across a few regulatory functions, Freyr, by virtue of being a one-stop-shop with an exclusive focus across the regulatory value-chain, providing end-to-end highly specialized, and cost-effective regulatory offerings in a low-cost, global delivery model has increasingly become a force to reckon with in the global regulatory service provider landscape.

Offering Array of Regulatory Solutions and Services Portfolio’s

• Regulatory Affairs & Operations
• Regulatory Submissions & Publishing Services
• Regulatory intelligence Services
• Regulatory Labeling & Artwork Services
• Regulatory Outsourcing Services
• Regulatory Strategy & Business Consulting
• Regulatory information Management & COTS
• Health Authority Directives

Territory of Clientele
Feyr has a client base of 6 companies from the Forbes Global Top 10, $20 billion Fortune 500 in the Pharma/Consumer Healthcare sector. In the Biotech sector, there are 2 companies from the Forbes Top 5, $20 billion Fortune 500. It has clients from the Global Top 20, $20 billion in the Innovator sector and from the Global Top 10, $2 billion in the Generics sector. In the mid-market segment, it has more than 6 clients in the $1 billion Bio Pharma/Consulting sector. In addition to this, they have more than 30 clients in the fast growing $1 million Life Sciences companies, CROs and standard agencies.

Freyr in Coming Years
The global regulatory environment is dynamic in nature and it is compounded by the ever changing regulatory mandates. Freyr is therefore aiming at transforming its solution capabilities to create highly differentiated next-generation solutions exclusively designed to address the Regulatory domains like Generics, Consumer Healthcare, Innovative and Complex Therapeutic Areas.

Additionally, the company is poised to expand its global footprint in new emerging and upcoming markets of Latin America, Asia Pacific, Africa and the Middle East. Freyr has also initiated a strategic program to create a global Partner Affiliate Network (PAN) across 120 countries for enhanced delivery excellence.

Get in touch: www.freyrsolutions.com

Knowing the Masters

Rajiv Rangan, Co-CEO
Holding more than 15 years of diverse expertise in setting up and growing businesses in Life Sciences (Services/Solutions) & Information Technology domains, Rajiv is experienced in business start-up, business acceleration, consulting, client services & marketing of Services & Solutions for Life Sciences industry with key focus in Regulatory functions (Additional areas – Clinical, Safety, CRM / SFA, Enterprise IT & Scientific Information Services functions). He also has background on innovation-driven software product development, outsourcing, High-end KPO / BPO & Product Development Services.

Suren Dheenadayalan, Co-CEO
A product of Birla Instituite of Technology & Science Pilani, Suren carries 15 years of experience in Regulatory, Clinical and Compliance functional areas within the life sciences industry, working both within big Pharmaceuticals and as a consultant to the industry. Prior to Freyr, he has worked with companies such as Merck, , Deloitte Consulting, FDA