Drug development is a time-consuming, costly and complex process that is linked to a high degree of uncertainty whether the drug will be a market success or a failure. Therefore, a clear and optimized Regulatory strategy is required to determine the future risks and accordingly formulate the risk-mitigation strategy for the successful launch of drug product.
ANDA strategic product planning provides a roadmap for each milestone during the drug development cycle for manufacturers to make sound investment decisions, along with prioritization and management, of the project portfolio.
Freyr assists clients in ANDA strategic product planning and submissions with optimum utilization of resources throughout the drug development process to maximize the probability of successful commercialization of drug products.
Preparation of Regulatory strategy and identification of reference drug product
Regulatory consultation for Quality by design (QbD) protocols
Finalization of APIs, excipients and packaging material specifications and tests
Development of a strategy for bioequivalent and stability studies
Guidance in prototype formula clearance and final formula clearance w.r.t IIG, dose proportionality, size and shape
Regulatory consultation for HA communication and query handling
Strategic consulting and Regulatory support for preparation and submission of ANDAs and DMF
Strategic support for the implementation of Post-approval changes
Competitors landscape evaluation and preparation of right Regulatory strategies that suits well for product registrations
Identification of the right approach for each case/clinical program/marketing authorization strategies
Orphan Drug applications (ODD)
Product Evaluation for suitability under expedited programs, and Regulatory support for submission of Expedited program requests
Consultation on QbD protocols and reports
Evaluation of excipients against IIG database
Consultation on protocols/reports for process validation, method validations, specifications, test methods, exhibit batch protocols, pilot-scale batches, commercial batch protocols, etc.
Consultation on defining the tests/risk assessment for genotoxic impurities, elemental impurities and nitrosamine impurities
Consultation on stability study requirements considering bracketing and matrixing concepts
Consultation on RLD selection
Consultation in the selection of dissolution parameters multimedia
Consultation on providing the response to HA queries