Any pharmaceutical or biological product intended for human use should be registered with the Health Authorities (HAs) as per country-specific requirements. As Regulatory submission(s) requirements are dynamic and different for each HA, they are being updated regularly by the Regulatory affairs services expert who has a thorough understanding of the requirements and keeps track of the updates. It is essential to manage the Regulatory submissions to avoid any rejections and to ensure on-time approvals.
Freyr, as a proven Regulatory affairs consultant for many global manufacturers in their Regulatory submissions, can provide end-to-end Regulatory affairs services to medicinal products manufacturers.
- Regulatory submission road maps/strategic reports for the identified medicinal products.
- Regulatory affairs services consultation during product development.
- Pre-submission technical meetings with the USFDA/EMA/other HAs.
- Correspondence with the global HAs for product registrations and approvals.
- Support for the finalization of composition of the medicinal products.
- Designing of specifications.
- Guidance in the preparation of protocols/reports for product development, process validation, exhibit batches, hold time studies, and stability studies.
- US/Canada local agent support.
- Support for all pre-submission administrative activities.
- Technical gap-analysis of the supporting documents/data.
- Guidance on additional/missing documents/data generation to mitigate the gaps.
- Authoring and reviewing CMC modules for initial submissions like INDs/IMPDs/CTAs.
- NDAs-505(b)2/Dossiers/BLAs for innovator pharma/biologics/biosimilars/vaccines.
- Authoring and reviewing CMC modules for initial submissions like ANDAs/ANDSs/MAAs/Dossiers and DMFs for generic products.
- Change controls evaluation and prepare submission strategy.
- Preparation of CMC packages for post-approval change submissions like supplements/variations/amendments.
- Preparation of CMC packages for life-cycle management submissions like Annual Reports/Renewals.
- Handling of HA queries with strategy and preparation of response packages.