The demand for drug and biological products is gaining momentum in Ukraine which in turn has resulted in a flourishing market for pharmaceuticals in the country. The Ministry of Health (MoH) is the responsible body for regulating and approving the import, manufacture, sale and marketing of medicinal products in Ukraine. To do so, a manufacturer must be adept in the Regulatory process of registering a medicinal product which span across product development to compilation to submissions. To obtain the market approval, timely analysis of the inadequacies can prove beneficial.
Freyr has dedicated resources to provide Regulatory support throughout the process of submission including obtaining an import license in stipulated timelines in a cost-effective manner. Freyr offers post-approval gap analysis to maintain continued compliance in line with changing regulations, and also extend pre and post-approval Regulatory assistance for health authority (HA) interactions such as communication for administrative activities and query responses respectively.
- Regulatory submission roadmap for medicinal products registration
- Regulatory consultation during the development of the medicinal products
- Pre-submission administrative activities, pre-submission interactions with health authority (HA)
- Gap analysis of generated data against Ukraine specific requirements for their adequacy
- Compilation and submission of the dossiers to HA in CTD format
- Assistance for strategy, compilation and submission of post-approval changes to Ukrainian HA
- CTD conversion of legacy products from old/paper format
- Designing of specifications for Active Pharmaceutical Ingredient (API), finished product & intermediates
- Limits for impurities including genotoxic & elemental
- Protocols Design for bio-equivalence, stability, analytical method validation, exhibit batch, process validation
- Change control evaluation and compliance activities
- Support for HA query response on pre and post-registration