We offer protocol based quality support and hand holding to your team in pharmaceutical and biologics development and technology transfer to derive the critical quality attributes, critical process parameters and tolerances within the GMP framework and scale up development to reproducible method and process technology transfer of product as per the current guidelines following QbD and QRM approaches.
. Systematic, Knowledge driven, Science & Risk based and Patient focused;
. Scale-up development for Pre-exhibit, Exhibit and Marketable scales;
. Deriving CQA, CPP and Design space – NCE, API, IND, ANDA;
. Development, qualification and validation of stability indicating method of analysis;
. Specifications on Mechanistic understanding of product, process and method;
. Continual improvement and ‘real-time’ Assurance of Quality.
. Product and process as a part of Process validation;
. Method qualification, validation and transfer;
. Research phase, development phase and production phase;
. Re-inventing the CPP & CQA and Certification on technical consensus;
. Process performance and monitoring, knowledge management, Post-approval changes in DS and DP.
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