Product Development Strategy for Generic Drug - Overview
In the realm of Product Development Strategy, drug development emerges as a time-consuming, costly, and complex process linked to a high degree of uncertainty regarding the market success or failure of the drug. As such, a clear and optimized Regulatory strategy is imperative. This strategy plays a crucial role in assessing future risks and formulating effective risk-mitigation plans to ensure the successful launch of the product.
Product-specific guidance for generic drug development provides a roadmap for each milestone during the drug development cycle for manufacturers to make sound investment decisions and prioritize and manage the project portfolio.
Freyr assists clients in their product development strategy and submissions with optimum utilization of the resources throughout the drug development process for the successful commercialization of drug products.
Product Development Strategy for Generic Drug - Expertise
- Preparation of the Regulatory strategy for drug development and identification of the reference drug product.
- Regulatory consultation for Quality by Design (QbD) protocols.
- Finalization of the APIs, excipients, and packaging material specifications and tests.
- Development of a product development strategy for bioequivalent and stability studies.
- Strategic 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 the preparation and submission of ANDAs and DMF.
- Strategic support for the implementation of post-approval changes.
- Competitors landscape evaluation and preparation of the right Regulatory strategies that suit product registrations.
- Identify the right approach for each case/clinical program/marketing authorization strategy.
- Orphan drug applications (ODD).
- Product evaluation for suitability under the expedited programs and Regulatory support for the submission of expedited program requests.
- Consultation on QbD protocols and reports.
- Evaluation of the excipients against the IIG database.
- Consultation on the 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 assessments for genotoxic, elemental, and nitrosamine impurities.
- Consultation on stability study requirements, considering bracketing and matrix concepts.
- Consultation on the Reference Listed Drug (RLD) selection.
- Consultation on the selection of dissolution parameters multimedia.
- Consultation on responding to HA queries.
