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What Makes an Innovator?

 
  • Patients, Caregivers and Society

    Form the backbone for everything we are
    trying to achieve as an industry

  • Efficient Regulatory Affairs

    Ensure that the drugs are safe and effective, reach the people who need them across the globe.

  • Pharmaceutical R&D

    Helps generate path-breaking innovator
    drugs and originator molecules that ensure betterment of lives

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Innovator Product Specific Services

Early-stage
  • Regulatory strategy for drug development
  • Technical consulting (CMC) on drug development issues
  • Pre-IND/BPD/ Scientific advice meeting support
  • Preparation of meeting requests, questions and background materials and justifications/ briefing packages
  • Representation for Agency meetings
  • Strategic support for post-meeting preparation activities
Clinical-Trials
  • IND/IMPD/ CTA dossier templates
  • Source data review/ gap analysis and Regulatory compliance support
  • Preparation of IND/IMPD/CTA packages
  • Regulatory support to manage clinical hold issues and HA queries/ Information requests
  • IND/IMPD/ CTA amendments
  • Annual reporting (as applicable) for clinical programs
  • End of clinical phase meetings with HA
Marketing-Authorization
  • Source data gap analysis for NDA/BLA/MAA dossier preparation
  • Regulatory risk mitigation/ remediation plans for identified gaps
  • NDA/BLA/MAA dossier templates
  • Preparation and submission of NDA/BLA/MAA/CSD applications
  • Support in handling HA queries/ information request/ amendments during review of application
  • Regulatory support to manage response to CR letters (Complete Response Letters)
Post-Approval
  • Regulatory support for strategy and planning of compliance for post approval commitments
  • Change controls assessment, Regulatory impact evaluation
  • Regulatory strategy for filing the variations/ supplements in global market
  • Preparation and submission of variation/ supplements packages to Health Authorities
  • Preparation of response to queries received from the Agencies
  • Annual reports submission
  • Administrative submissions such as License Holder transfer, MA holder address changes
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Freyr is Probably the First and the Only Global Regulatory Consulting Firm to Say…

Forget Regulatory Affairs

The pharmaceutical innovation model is remarkably robust and MNCs, small companies and virtual companies alike, have been very successful in maintaining their market dominance over the years owing to a strong NME pipeline and focus on R&D.

Which is why we urge you, to…

Focus on Innovation

Countries with a highly demanding Regulatory apparatus, like the United States and the UK, have promulgated an era of a competitive and innovative Pharmaceutical industry. This is in lieu of their stringent Regulatory requirements that in turn ensure that companies are more selective in the molecules that they bring to market.

With a strong global team of 1000+ Regulatory affairs experts, and a combined millennium and more of experience, we are poised to, and we are confident that…

We’ll Handle Your Regulatory

  • 01Do you have a unique drug technology that was never approved by Health Authorities before?
  • 02Are you developing drugs for rare diseases?
  • 03Are you exploring new therapeutic areas with novel drug candidates?
  • 04Are you looking for the right strategy for your drug development and global commercialization?
  • 05Are you a company that has purchased a molecule still in clinical trials?
  • 06Are you a company that has a long pipeline of innovators?
  • 07Are you a virtual company looking to expand into multiple global market?

If your answer to any of these is “yes”…

If you do not have an in-house Regulatory affairs team …

If your in-house team needs support in terms of global expertise and resources …

Come Talk to Us

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regulatory-system

From the Eureka moment to the actual filing, and even after that (it's not over till it actually is) Freyr acts as a strategic Regulatory partner providing end-to-end Regulatory solutions and services.

The Innovator Drug Development Process

Clinical Trials ~ 6 Years

The Innovator Drug Development Process
  • The Innovator Drug Development Process
  • The Innovator Drug Development Process

    Discovery Phase & PreClinical Studies 6 Years

  • The Innovator Drug Development Process
  • The Innovator Drug Development Process

    Phase 1

  • The Innovator Drug Development Process
  • The Innovator Drug Development Process

    Phase 2

  • The Innovator Drug Development Process
  • The Innovator Drug Development Process

    Phase 3

  • The Innovator Drug Development Process
  • The Innovator Drug Development Process

    Regulatory Review
    0.5 - 2 Years

  • The Innovator Drug Development Process
  • The Innovator Drug Development Process

    PMS

  • The Innovator Drug Development Process
  • The Innovator Drug Development Process

    Exclusivity

The Innovator Drug Development ProcessThe Innovator Drug Development ProcessThe Innovator Drug Development Process
  • IND Submission to USFDA
    IMPD Submission in EU
  • NDA Submission to USFDA
    MAA Submission in EU
  • 12Years Market Exclusivity
    8+2+1 Market Exclusivity

Global Locations

  • Global Locations120+ Countries
  • &
  • Global Locations13+ Regulatory Hubs
Global Locations
  • Canada
    Regional Office

  • Mexico
    Regulatory Hub
    for LATAM

  • USA
    Regulatory Hub
    for North America

  • Germany
    Regulatory Hub
    for EU Region

  • UK
    Regulatory
    Hub for UK

  • Poland
    Regional Office

  • Slovenia
    Delivery Hub for Eastern Europe

  • India
    Global Delivery Hub

  • Sri Lanka
    Regional Office

  • South Africa
    Regional Office

  • Malaysia
    Regional Office

  • Singapore
    Regional Office

  • Australia
    Regional Office

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Global Locations background
Global Locations background

Regulatory Competencies

Compliance, Audit And Validation

  • GxP Audit Services
  • QMS Remediation Services
  • Process and Product Validation
  • GxP Solution Consulting
  • Clinical Trial Audit and Monitoring Services
Know More
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    Innovator Projects
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    Post Approval 
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    Submission
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    Labels Processed
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    NDAs(505(b)(1))
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    MAAs(Article 8(3))
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    Regulatory partner
    for development of
    120+ Drug Candidates
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    INDs
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    CTA
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    Pre-Submission
    meetings
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    Scientific Advice
    Meetings
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    Renewals
    meetings
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Latest Resources

  • Blogs

    ANVISA Becomes a Member of PIC/s Committee

    ANVISA Becomes a Member of PIC/s Committee

    Read More
  • White Papers

    Factors that May Cause FDA to Refuse to Receive (RTR) an ANDA

    Factors that May Cause FDA to Refuse to Receive (RTR) an ANDA

    Read More
  • Webinars

    Strategic Regulatory Partnerships How to Evaluate & Engage with a Regulatory Partner

    Strategic Regulatory Partnerships How to Evaluate & Engage with a Regulatory Partner?

    Read More

What Our Clients Say?

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