Registration of a Marketing Authorization Application (MAA) for a medicinal product will provide access to all the EU member states for Marketing Authorization Holders (MAHs) or pharmaceutical manufacturers to manufacture and distribute.
Though the harmonized Regulatory requirements by 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, expertise in Health Authority interactions, and MAA registration activities (MAA submissions) to avoid validation rejections and major clock-stops that will delay the marketing authorization approval process.
In the generic drug approval process, the manufacturer or the sponsor of a generic medicinal product should select a specific MAA procedure such as the Centralized Procedure (CP), National Procedure (NP), Mutual Recognition Procedure (MRP), and Decentralized Procedure (DCP) for registration and placing the medicinal product in the EU.
Freyr, having established offices in multiple EU countries, can be a cost-effective and trust-worthy Regulatory partner for pharmaceutical manufacturers to handle the generic drug approval process including legal and administrative requirements, along with MAA registration support for the medicinal products through Article 8(3) (for innovator products) and Article 10(1) routes (for generic medicinal products). Freyr assures the pharmaceutical manufacturers and/or MAHs on legal and procedural compliance for registration and distribution of their products in the EU countries.
Legal representation as an MAH for the medicinal product manufacturers with no establishments in the European Economic Area (EEA).
Regulatory consultation/strategic support during the development stage of the generic medicinal products.
Advice applicants in the selection of appropriate MAA registration procedures.
Advice for appointment/consultation of Qualified Person (QP) and Qualified Person for Pharmacovigilance (QPPV) (if the applicant office is not in the EEA and they don’t have their own QP and QPPV).
Guidance in the selection of test product and reference medicinal product bio-batch for bio-equivalence study.
To provide support in the selection of dissolution parameters/multimedia for performance of dissolution for test product and reference medicinal product.
Review support for manufacturers during development stage of the product (discriminatory nature of media).
Finalization of the specifications for Finished Products (FPs), in-process/intermediates, and review of protocols/reports for exhibit batches/stability study.
Regulatory assessment/gap-analysis of source documents/already registered dossier for their Regulatory adequacy.
Slot booking for MAA submission.
Liaise with specific countries to act as RMS for DCP MAA filing.
Compiling, technical reviewing, finalizing, publishing, and submission of MAA to the EU HAs.
Regulatory strategy in response to HA queries (RTQs).
Prepare responses to HA queries (HAQs) with supporting documents/data with the scientific rationale to avoid delay in approval.
Follow-up with Regulatory agencies throughout the generic drug approval process.