Overview
Drug development is a time-consuming, costly, and complex process that is linked to a high degree of uncertainty on 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 to accordingly formulate the risk-mitigation strategy for successful launch of the 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 their 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.
Freyr Expertise
- 01
Preparation of Regulatory strategy and identification of reference drug product.
- 02
Regulatory consultation for Quality by Design (QbD) protocols.
- 03
Finalization of APIs, excipients, and packaging material specifications and tests.
- 04
Development of a strategy for bioequivalent and stability studies.
- 05
Guidance in prototype formula clearance and final formula clearance w.r.t IIG, dose proportionality, size, and shape.
- 06
Regulatory consultation for HA communication and query handling.
- 07
Strategic consulting and Regulatory support for the preparation and submission of ANDAs and DMF.
- 08
Strategic support for the implementation of post-approval changes.
- 09
Competitors landscape evaluation and preparation of the right Regulatory strategies that suit product registrations.
- 10
Identification of the right approach for each case/clinical program/marketing authorization strategies.
- 11
Orphan drug applications (ODD).
- 12
Product evaluation for suitability under expedited programs and Regulatory support for submission of expedited program requests.
- 13
Consultation on QbD protocols and reports.
- 14
Evaluation of excipients against IIG database.
- 15
Consultation on protocols/reports for process validation, method validations, specifications, test methods, exhibit batch protocols, pilot-scale batches, commercial batch protocols, etc.
- 16
Consultation on defining the tests/risk assessment for genotoxic impurities, elemental impurities, and nitrosamine impurities.
- 17
Consultation on stability study requirements considering bracketing and matrixing concepts.
- 18
Consultation on RLD selection.
- 19
Consultation on the selection of dissolution parameters multimedia.
- 20
Consultation on providing responses to HA queries.
USA
UK
GERMANY
INDIA