When it comes to regulatory strategies, CMC documentation play a crucial role in developing efficient regulatory approaches for pharmaceuticals as well as biological products. CMC documentation is crucial when the goal is to release data for multiple markets, with minimal or no additional documentation.
DDReg’s CMC services is dedicated to assisting customers in developing robust and an efficient regulatory strategy through all development phases -authoring, preparing, reviewing and submitting all necessary documentation. With a decade plus of experience, DDReg’s CMC services utilizes optimal data generation to maximize the quality filings worldwide.
QbD planning involves ensuring that there are appropriate tools in place during product design phases so that, sound quality processes can be created as early in the process as possible. The knowledge base section of DDReg’s QbD Planning tool addresses this need. It provides specific guidance on how various aspects should be considered and addressed within drug products ranging from APIs through manufacturing practices such as stability studies, excipients selection/characterization and others, sterilization techniques. For example: predictive sterility assessment; containment systems used such closures/vial stoppers/integrity tests – extractable leachable rates with recommendations for suitable testing methods & standards). There are also guidelines about what standards must be met at different stages throughout pharmaceutical lifecycle management (PLM), starting from requirements related to qualification status up until post market surveillance phase.
Summary of DDReg’s CMC advisory expertise include:
- QbD planning
- Injectable Packaging – Extractable & Leachable, Sterilization
- Drug Device Combination products
- API Selection based on KSM
- Exhibit Batches
- Review of CMC documentation for new product registrations, post approval submission and follow-up closely on queries and through approval.
- CMC section preparation and review (Module 3, Module 2.3 and relevant Module 1 documentation).
- CMC regulatory intelligence.