Regulatory Affairs Services

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Overview

Overview

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 a Regulatory expert, who has a thorough understanding of the requirements and keeps a track of the updates. It is essential to manage the Regulatory submissions to avoid any rejections and to ensure on time approvals. A Regulatory affairs services provider can help setup process for operational excellence to ensure this timeliness.

Freyr as a proven Regulatory affairs service provider and 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 identified medicinal products
  • Regulatory affairs consultation during  product development
  • Pre-submission technical meetings with the USFDA/EMA/other HAs
  • Correspondence with 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 review of CMC Modules for initial submissions like INDs/IMPDs/CTAs/
  • NDAs/505(b)2/Dossiers/BLAs for innovator Pharma/Biologics/Biosimilars/Vaccines
  • Authoring and review of 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 package