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
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.