Regulatory Staffing Services

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Overview

Regulatory Staffing Services – An Overview

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

Freyr, a Regulatory contract staffing services partner, will help you overcome the resource gaps on time. We have a track record of successful and on-time resource deployment to ensure that the clients meet their organizational needs.

Freyr Expertise and Advantages

Freyr Expertise

Regulatory CMC Strategist:

  • Regulatory consultation during the product development & manufacturing phases for the 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, manage the team, and file the Regulatory submissions.
  • Be the 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 the 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.
  • Gap analysis/Regulatory assessment of generated source data for Regulatory adequacy.
  • Review the draft CTD sections for initial submissions like INDs/IMPDs/NDAs/MAAs/BLAs/Dossiers/DMFs and post-approval/LCM submissions like supplements/variations/amendments/annual reports/renewals.
  • Guide the other stakeholders on the Regulatory requirements for various submissions.
  • Managing the team for tracking upcoming submissions, quality deliveries, and meeting timelines.
  • Provide 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 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 the submission timelines and quality.
  • Coordination with multiple stakeholders for additional/missing documents/data.
  • Conducting knowledge-sharing sessions.
  • Tracking the upcoming submissions and managing the submission timelines.
  • Preparation of responses to Health Authority queries.
i>Preparation of responses to Health Authority queries.

Regulatory Staffing Services – Freyr Advantages

  • Regulatory contract staffing services for global clients.
  • Address specific Regulatory needs w.r.t staffing.
  • Offer proven Regulatory contract staffing expertise.

Address Resource Gaps with Regulatory Staffing Services

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