Regulatory Compliance and Gap Analysis – An Overview
Regulatory compliance and gap analysis of the supporting documents/data are critical for registering medicinal products. Though most Health Authorities (HAs) accept applications/dossiers in the CTD format, the content to be provided in the CTD section may vary. Thus, a thorough Regulatory gap analysis/technical assessment of the documents/data enables manufacturers to identify and mitigate the gaps before the submission. It avoids submission rejections and minimizes any major/critical queries to hasten the approvals.
Gap analysis of the legacy dossiers against the current practices followed for the medicinal product’s manufacture ensures Regulatory compliance. The identified gaps can be mitigated by the submission of probable supplements/variations to avoid non-compliance. Freyr, as a proven service provider with experienced Regulatory Affairs CMC resources, provides Regulatory gap analysis support.
Regulatory Compliance and Gap Analysis - Freyr Expertise
- Assessment of the Regulatory submission strategy.
- Gap analysis of the supporting documents/data generated during the development stage of the medicinal product.
- Review of the qualitative and quantitative compositions of the medicinal product for acceptability.
- Ensure the impurity limits are in line with the ICH requirements based on the Maximum Daily Dosage (MDD).
- Regulatory 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 the existing dossier for market expansion.
- Region-specific stability study requirements.
- Regulatory compliance requirements.
- Gap analysis of the draft CTD package to ensure the adequacy for submissions like INDs/IMPDs/CTAs/NDAs/MAAs/DMFs/Dossiers.
- Technical review of change controls.
- Regulatory gap analysis of the variation/supplement submission strategy and suggestions.