Regulatory Affairs Services

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Overview

Overview

Any Pharmaceutical or Biological product intended for human use should be registered with 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.

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  identified medicinal products
  • Regulatory 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