Change Control Evaluation and Submission Strategy - Overview
A strong Submission Strategy is crucial for managing changes that impact the approved content of the application. Such changes necessitate a comprehensive assessment to ascertain the most suitable course of action. In the pharmaceutical sector, the change control process and the assessment of the impact on ANDS/DIN/DMF should encompass a deep comprehension of the alteration, visibility into all affected products (including finished products and APIs), and the identification of all countries where these products are registered. Additionally, this process might extend to countries where a new product submission or approval is pending.
As the registered details for a product can differ between countries, it is essential to review all the amendments of relevant information so that a complete change control impact assessment can be performed, considering the regulations and guidelines applicable in the intended country (i.e., Canada), where the product is approved. The assessment will determine the classification of the change and the required supporting documentation.
A robust change control assessment of the product is critical in developing a suitable ANDS/DIN/MF change submission strategy and ensuring continued product compliance. Freyr’s Regulatory affairs team, with domain knowledge of research, manufacturing, quality, change control evaluation/assessment, post-approval submission strategy, and preparation of change-related submission packages in alignment with Health Authority requirements and guidelines, can support in your end-to-end pharma change control activities.
Change Control Evaluation and Submission Strategy - Expertise
- Evaluation of change control and supporting documents in line with HC post-approval submission guidelines
- Preparation of a post-approval submission strategy for the proposed change
- Providing the list of supporting documents/data to be included/generated
- Guidance on the implementation strategy for the proposed change
- Preparation of supporting Regulatory documentation (e.g., revised Module 3 sections, Module 1 documentation) for finished products and APIs.
