A Global Regulatory Solutions & Services Company

Freyr has grown to be a trusted Regulatory partner to 1100+ global customers, including 8 of the Global Top 10 Drugs and Biotechnology Companies, 5 of the Top 10 Med Tech and Healthcare Equipment and services companies,  3 of the Global Top 10 Household & Personal Product Companies, 3 of the Global Top 10 Chemicals Companies, and 2 of the Global Top 10 Food & Drink Companies, and 100s of Mid-market $1+ Billion BioPharma, and Several Small and Medium, Fast Growing Life Sciences companies, CROs, and Standards Agencies. 

Freyr has pioneered specialized Centers of Excellence (CoEs) exclusively focusing on the entire Regulatory value-chain supported by rapidly growing 1600+ In-house Regulatory Professionals.

Quick Facts

Strategic Regulatory Solutions & Services Partner to

  • 8 Forbes Global Top 10 Drugs & Biotechnology Companies
  • Forbes Global Top 10 Health Care Equipment & Services
  • 3 Forbes Global Top 10 Household & Personal Product Companies
  • Forbes Global Top 10 Chemicals Companies
  • 2 Forbes Global Top 10 Food & Drink Companies
  • 135+ Innovator Pharma Companies
  • 50+ Bio-Tech / Bio-Similar Companies
  • 135+ CROs / Consulting Companies

1100+ Clients

  • 280+ Medical Device Companies
  • 370+Consumer Companies
    (Cosmetics / Food and Food Supplements)
  • 180+Generic Companies / API Manufacturers
  • Global Presence
    USA, UK, Canada, Germany, UAE,
    Mexico, Singapore, Malaysia, South Africa, Sri Lanka, Slovenia, Poland, Australia, France, Switzerland, China, Japan, Brazil & India (Global Delivery Center)

  • ISO 9001 and ISO 27001 Certified

  • 950+ In-country Regulatory Affiliates
    Across 120+ Countries

  • 1600+ In-house Global Regulatory Experts and Growing

Regulatory Competencies

Exclusively focusing on the entire Regulatory value-chain, Freyr leverages its domain expertise and technology innovations to evolve hi-end, next generation Regulatory solutions and services that enable accelerated performance, operational excellence and significant cost and compliance benefits to clients.

Regulatory Affairs

Comprehensive Regulatory affairs for new product and market authorizations, Health Authority submissions, post-approvals, CMC and lifecycle management.

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Market Access & Regulatory Intelligence

Enabling Life Sciences organizations reach global markets with impeccable product, market and Regulatory pathway strategies, Regulatory intelligence, and enterprise process consulting.

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Publishing & Submissions

Streamlining entire publishing and submission management process right from planning, dossier development, tracking, publishing, submissions and delivery confirmation/acknowledgement.

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Regulatory Labeling

End-to-end labeling services and software support for global and regional labeling management, CCDS creation and updation, core to local label alignment etc.

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Artwork Pack
Management

Innovative, and cost-effective Regulatory artwork design & pack management services and software to support new product launches and brand re-designs.

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Regulatory Medical Writing

World-class Regulatory and medical writing services to put across scientific and clinical information in a clear, concise and compliant way.

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Compliance & Validation Services

Specialized GxP audit, QMS Remediation, Process and Product Validation and GxP Solution consulting services to assist Life Sciences organizations comply with Health Authority requirements.

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Regulatory Software

Freyr offers complete suite of Regulatory tools and software services that match to client requirements; be it publishing and submissions, labeling, Regulatory intelligence, Regulatory document management, trail master files, IDMP, and end-to-end UDI compliance solution.

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Pharmacovigilance

Pharmacovigilance is one of the most important functions within Life science companies. Pharmacovigilance (PV), also known as Drug Safety, relates to two (02) major aspects of any drug formulation/medical intervention with therapeutic benefit, safety, and efficacy. The first is to know whether a drug works, and the second is to decode safety.

 

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Mergers & Acquisitions

At Freyr, our Regulatory Strategy Consulting team understands the ins and outs of the pre-, during, and post- transition processes. Our SoMAD segment serves as a Transition Management Office, while the companies work on establishing their new identity.

 

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