Regulatory Affairs Services

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Any pharmaceutical or biological product intended for human use should be registered with the Health Authorities (HAs) as per country-specific requirements. As Regulatory submission(s) requirements are dynamic and different for each HA, they are being updated regularly by the Regulatory affairs services expert who has a thorough understanding of the requirements and keeps track of the updates. It is essential to manage the Regulatory submissions to avoid any rejections and to ensure on-time approvals.

Freyr, as a proven Regulatory affairs consultant for many global manufacturers in their Regulatory submissions, can provide end-to-end Regulatory affairs services to medicinal products manufacturers.

Freyr Expertise and Advantages

Freyr Expertise

  • Regulatory submission road maps/strategic reports for the identified medicinal products.
  • Regulatory affairs services consultation during product development.
  • Pre-submission technical meetings with the USFDA/EMA/other HAs.
  • Correspondence with the global HAs for product registrations and approvals.
  • Support for the finalization of composition of the medicinal products.
  • Designing of specifications.
  • Guidance in the preparation of protocols/reports for product development, process validation, exhibit batches, hold time studies, and stability studies.
  • US/Canada local agent support.
  • Support for all pre-submission administrative activities.
  • Technical gap-analysis of the supporting documents/data.
  • Guidance on additional/missing documents/data generation to mitigate the gaps.
  • Authoring and reviewing CMC modules for initial submissions like INDs/IMPDs/CTAs.
  • NDAs-505(b)2/Dossiers/BLAs for innovator pharma/biologics/biosimilars/vaccines.
  • Authoring and reviewing CMC modules for initial submissions like ANDAs/ANDSs/MAAs/Dossiers and DMFs for generic products.
  • Change controls evaluation and prepare submission strategy.
  • Preparation of CMC packages for post-approval change submissions like supplements/variations/amendments.
  • Preparation of CMC packages for life-cycle management submissions like Annual Reports/Renewals.
  • Handling of HA queries with strategy and preparation of response packages.