Overview
Russian medicinal product market is perceived with positive outlook. The demand projections are in support of this trend. Roszdravnadzor (or) Federal Service for Supervision in Health Care functioning under the Ministry of Health (MoH) supervises and approves, the distribution and marketing of medicinal products for human and veterinary purposes. However, to obtain market entry in a compliant way, manufacturers should follow a stringent Regulatory process.
By keeping track of changing regulations in Russia, Freyr assists new market entrants and existing manufacturers with an accurate Regulatory submission roadmap for successful compliance. Freyr’s Regulatory offerings include post-approval Regulatory assistance for change control evaluation, strategic HA query response and other dossier submissions for re-registrations without deviating from local health authority guidelines.
Freyr Expertise
- Regulatory submission roadmap for medicinal products registration
- Regulatory consultation during the development of the medicinal products
- Expert team for handling Normative Documents (ND) of Regulatory submissions
- Pre-submission administrative activities, pre-submission interactions with health authority (HA)
- Regulatory assessment of source data for their adequacy
- Guidance for data generation and performing gap analysis
- Compilation and submission of the dossiers to HA in CTD format
- Assistance for strategy, compilation and submission of post-approval changes
- 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
- Dossier submissions for re-registration to ensure continuity of product supply in market