Global Regulatory Affairs Experience

Freyr is the leading Regulatory affairs services organization and has been a pioneer in offering strategic multidisciplinary Regulatory affairs consulting services worldwide. Freyr provides comprehensive Regulatory affairs services throughout the spectrum of global product development, registration and commercialization. To assist organizations maximize their product’s commercial capability and market success, Freyr partners with organization's in-house teams to deliver informed advice and Regulatory affairs consulting offerings and solutions for brand new product and marketplace authorizations, Health Authority submissions, submission approvals, CMC and lifecycle management.

Freyr’s worldwide Regulatory affairs offerings enable Life Sciences, Consumer Pharma and Bio-Med companies to understand and successfully manage the demanding complexity of various Regulatory requirements so as to correctly launch their products in new markets and maximize their market value.

EUROPE, AUSTRALIA, NZ

  • Regulatory strategy and submission roadmaps
  • Support in identifying the submission procedures
  • Meetings with EMA/other HAs
  • Content for pre-submission meetings
  • CMC writing of IMPD/MAA/Hybrid Applications/ASMF/CEP
  • Pre-GMP clearance application for TGA
  • Product roll-out
  • Post-approval submissions (i.e. variations)
  • Lifecycle management i.e. renewals filings
  • Response to Queries
  • Legacy dossiers gap analysis and remediation
  • End-to-end Regulatory consultation
  • Change control evaluation and compliance support
  • Site transfers

NORTH AMERICA

  • Regulatory strategy and submission roadmaps
  • Packages for pre-submission meetings for INDs/NDAs/ANDAs
  • CMC writing of IND/NDA(505(b)1/2)/ANDA/ANDS/DMF
  • Updating paper  INDs into eCTD format
  • Response to queries
  • Change control evaluation and compliance support
  • Lifecycle management (i.e. annual reports, amendments, and supplements)
  • Gap analysis and remediation
  • End-to-end Regulatory consultation
  • Updating USA DMF in line with the current GDUFA requirements
  • Updating paper DMFs into electronic DMFs

AFRICA, CIS, SSA

  • Regulatory strategy and submission roadmaps
  • CMC writing of MAA/DMF
  • Renewals
  • Update of DMFs in CTD/eCTD format
  • Product roll-out
  • Response to queries
  • Post-approval changes
  • Gap analysis and remediation
  • End-to-end Regulatory consultation
  • Site transfers

ASIA PAC, MIDDLE EAST

  • Regulatory strategy and submission roadmaps
  • CMC writing of dossiers/DMFs
  • Gap analysis and remediation
  • End-to-end Regulatory consultation
  • Site transfers

LATIN AMERICA

  • Regulatory strategy and submission roadmaps
  • CMC writing of dossiers/DMFs
  • Gap analysis and remediation
  • End-to-end Regulatory consultation

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

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