Regulatory Staffing Services

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Overview

Overview

To maintain the confidentiality of the medicinal products and have a complete visibility of the Regulatory activities on a daily basis, manufacturers prefer to have the external Regulatory affairs staffing support. But today, the biggest challenge the industry faces the biggest challenge of finding the qualified Regulatory talent.

Freyr – a Regulatory contract staffing partner will help you overcome the resource gaps on time. Freyr has a track record of successful and on-time resource deployment to ensure clients meet their organizational needs. Freyr extends on-time Regulatory affairs staffing for:

Freyr Expertise and Advantages

Freyr Expertise

Regulatory CMC Strategist:

  • Regulatory consultation during product development & manufacturing phase for selection of RLD/Reference Standard
  • Guidance in designing the specifications, protocols/reports for development, process validation, exhibit batches, stability studies
  • Confirmation of composition against Reference drug
  • Interaction with different stakeholders of manufacturing and research quality on the Regulatory aspects
  • Support in the interaction with the Health Authorities
  • Provide Regulatory submission strategies and road maps
  • Provide Guidance and managing the team and Regulatory submissions
  • Interface between the management team and the Regulatory Affairs team
  • Handling of Health Authority queries with strategies and scientific justifications

Regulatory CMC Expert:

  • Prepare Regulatory submission strategies for respective submissions and execute
  • Provides change controls evaluation and post-approval submission strategies
  • Provide the documents checklist for all types of Regulatory submissions
  • Regulatory consultation during product development & manufacturing phase for selection of RLD/Reference Standard
  • Guidance in designing the specifications, protocols/reports for development, process validation, exhibit batches, stability studies
  • Confirmation of composition against Reference drug
  • GAP analysis/Regulatory assessment of generated source data for Regulatory adequacy
  • Review of the draft CTD sections for initial submissions like INDs/IMPDs/NDAs/MAAs/BLAs/Dossiers/DMFs and for post approval/LCM submissions like, Supplements/Variations/Amendments/Annual Reports/Renewals
  • Guidance to other stakeholders on the Regulatory requirements for various submissions
  • Managing the team for tracking of upcoming submissions, quality deliveries and meeting the timelines
  • Guidance to the team on Regulatory updates and requirements
  • Preparation of Response submission strategy for HA queries and review of the draft response package

Regulatory CMC Associate:

  • Gap analysis of source documents/data for the adequacy
  • Authoring of CMC modules for initial submissions like, INDs/IMPDs/NDAs/ MAAs/BLAs/Dossiers/DMFs
  • Authoring of CMC packages for post approval/LCM submissions like, Supplements/Variations/Amendments/Annual Reports/Renewals
  • Provides change controls evaluation and post-approval submission strategies
  • Tracking of Life cycle management submission timelines for Annual Reports/Renewals
  • Provide the documents checklist for all types of Regulatory submissions
  • Implementation of Regulatory submission strategies
  • Managing submissions timelines and quality
  • Coordination with multiple stakeholders for additional/missing documents/data
  • Having knowledge sharing sessions
  • Tracking the upcoming the submissions and managing the submission timelines
  • Preparation of Response to Health Authority Queries