Regulatory Staffing Services - Overview
To maintain the confidentiality of medicinal products and have complete visibility of the Regulatory activities daily, manufacturers prefer external Regulatory staffing services’ support. But today, the biggest challenge the industry faces 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.
Regulatory Staffing Services
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 document 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
- Guide 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 document 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
- Regulatory contract staffing services for global clients
- Address specific Regulatory needs concerning staffing
- Offer proven Regulatory contract staffing expertise
