Changes with the potential to impact approved content of the application require a thorough assessment to determine the appropriate course of action. The change control impact assessment of ANDS/DIN/DMF must include a full understanding of the change, visibility of all impacted products (i.e., finished products and APIs), and must determine all countries where those products are registered. This might also include countries where a new product submission or approval is pending.
As registered details for a product can differ between countries, it is essential to review all the amendments of relevant registered information so that a complete change control impact assessment can be performed taking into account the regulations and guidelines applicable in the intended country (i.e. Canada), where the product is approved. The change control impact 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 for ensuring continued product compliance. Freyr’s Regulatory affairs team with domain knowledge of research, manufacturing and quality in addition to Regulatory with in-depth understanding and experience in change control evaluation/assessment, post-approval submission strategy and preparation of change-related submission packages in alignment with Health Authority requirements and guidelines.
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