Registration of a single Marketing Authorization Application (MAA) for medicinal product provides access to the Marketing Authorization Holders (MAHs)/Pharmaceutical manufacturers to manufacture and distribute in all the EU member states.
Although the harmonized Regulatory requirements of all the EU member states eases the development and documents generation activity for pharmaceutical manufacturers, the complexity of the procedural requirements will need a Regulatory expert with complete understanding on the EU country-specific requirements, Health Authority interactions, and Marketing Authorization Application registration activities (MAA submissions) to avoid validation rejections, major clock-stops which will delay the marketing authorization approval process and go-to market timelines.
Freyr, having established offices in multiple EU countries, assists pharmaceutical manufacturers to handle all the legal and administrative requirements along with registration support for the medicinal products through Article 8(3) (for innovator products) and Article 10(1) routes (for generic medicinal products), which enables the manufacturers and/or MAHs assurance on legal and procedural compliance for registration and distribution of their products in the EU countries.
- Guidance in the selection of Test Product and Reference Medicinal Product (RMP) bio-batch lot for bio-equivalence studies.
- To provide support in selection of dissolution parameters/multimedia for performance of dissolution for Test Product and RMP.
- Support in the preparation of Product Development Report (discriminatory nature of media).
- Finalization of the specifications for finished products, in-process/intermediates, and review of protocols/reports for exhibit batches/stability study.
- Advice in the selection of Regulatory submission procedure i.e., Centralised Procedure (CP), National Procedure (NP), Decentralised Procedure, (DCP) or Mutual Recognition Procedure (MRP).
- Slot booking for MAA submissions.
- Liaise with specific countries to act as RMS for DCP MAA filing.
- To provide advice for appointment of Qualified Person (QP) and Qualified Person for Pharmacovigilance (QPPV).
- To provide advice for consultation of batch release testing site and batch control site testing.
- Technical gap-analysis of source documents/data for adequacy against EU countries’ specific requirements.
- Compilation, technical review, finalization, publishing, and MAA submission in the eCTD format.
- Regular follow-ups with Health Authorities.
- Handling Health Authority queries with strategies and preparation of response package for submission for MAA.
- Translation support during the national phase of the registration in all the EU languages.