Regulatory Staffing Services

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Overview

Overview

To maintain the confidentiality of the medicinal products and have complete visibility of the Regulatory activities on a daily basis, manufacturers prefer to have external Regulatory affairs staffing support. But today, the biggest challenge the industry faces is finding 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 that the 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 phases for selection of RLD/Reference Standard.
  • Guidance in designing the specifications, protocols/reports for development, process validation, exhibit batches, stability studies, etc.
  • Confirmation of composition against the reference drug.
  • Interaction with different stakeholders of manufacturing and research quality on the Regulatory aspects.
  • Support in interaction with the Health Authorities.
  • Provide Regulatory submission strategies and roadmaps.
  • Provide guidance, 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 them.
  • Provide 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, etc.
  • Confirmation of composition against the 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 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.
  • Provide change controls evaluation and post-approval submission strategies.
  • Tracking of lifecycle management submission timelines for Annual Reports/Renewals.
  • Provide a 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 submissions and managing the submission timelines.
  • Preparation of responses to Health Authority queries.