Regulatory Assessment/Gap analysis of the supporting documents/data is very critical for the registration of medicinal products. Though most of the Health Authorities (HAs) accept applications/dossiers in the CTD format, the level of content to be provided in the CTD section vary from each other. Thus, a thorough gap analysis/technical assessment of the documents/data enables the manufacturers to identify and mitigate the gaps before Regulatory submission. It will avoid Regulatory rejections of the submissions and minimize the major/critical queries to fasten the approvals.
Gap analysis of the legacy dossiers against current practices followed for the manufacture of the medicinal products will ensure the Regulatory compliance of the product. The identified gaps can be mitigated by the submission of the probable supplements/variations to avoid the non-compliant Regulatory practices.. Freyr, as a proven Regulatory service provider with the experienced Regulatory affairs CMC resources, provides gap analysis support.
- Assessment of the Regulatory submission strategy
- Regulatory Compliance/Gap analysis of the supporting documents/data generated during the development stage of the product
- Review of the qualitative and quantitative composition of the medicinal product for acceptability
- Impurity limits in line with ICH requirements based on MDD
- Gap analysis of the protocols/reports for product development, process validation, stability program, exhibit batches, batch size for registration and hold time study
- Dissolution method/parameters selection
- Biowaiver criteria
- Assessment of existing dossier for market expansion
- Region-specific stability study requirements
- Gap analysis of draft CTD package to ensure the adequacy for submissions like, INDs/IMPDs/CTAs/NDAs/MAAs/DMFs/Dossiers
- Technical review of change controls
- Gap analysis of the variation/supplement submission strategy and suggestions