Regulatory & Registration

On-Bir enables registration in Türkiye through a scientist-led regulatory team that translates complex TMMDA expectations into a clear, submission-ready plan. Unlike GMP compliance-only providers, we connect Türkiye CTD/eCTD readiness to EU-GMP alignment, supplier audit evidence, and CMC documentation so the file is defensible from day one. We offer end-to-end dossier preparation, submission management and lifecycle support.

On-Bir provides EU registration services with a scientist-led team that combines regulatory strategy, CMC documentation and quality evidence to support centralised, DCP/MRP or national pathways. Our customized, high-touch model accelerates responses to authority questions and prevents late-stage dossier rework by addressing Module 3 quality issues and variations planning early.

On-Bir supports registration in the region (EMEA, MENA and CIS) by combining local-market regulatory intelligence with a practical commercial route-to-market built on our regional distributor network. Our scientist-led team aligns each country dossier with EU-GMP certificate, CMC documentation and supply-chain feasibility to avoid 'approval-but-no-launch' outcomes.

On-Bir provides specialized dossier improvement services to enhance the quality, completeness, consistency, and regulatory compliance of existing pharmaceutical registration dossiers. Our expert team conducts comprehensive reviews of CTD/eCTD documentation, identifies technical and regulatory gaps, and provides targeted solutions to strengthen dossier quality, address deficiencies, and ensure alignment with current regulatory requirements and expectations.

On-Bir handles dossier technical updates across the product lifecycle, including variations, renewals and next-format conversions, with disciplined control of CTD/eCTD structure. Our regulatory scientists keep quality, clinical and nonclinical sections consistent, updating CMC documentation, specifications and module summaries to match current EU and Türkiye guidelines.

On-Bir performs regulatory dossier due diligence & GAP analysis to de-risk acquisitions, licensing deals, and new registrations before you commit budget and timelines. Our scientist-led team reviews CTD completeness and technical soundness (especially Module 3 CMC), cross-checking EU-GMP readiness, site compliance and data integrity to flag approval and inspection risks early.

On-Bir can act as Marketing Authorisation Holder (MAH) in Türkiye and in Europe for companies that need a compliant local presence to commercialise medicinal products. Beyond holding the licence, our scientist-led team integrates EU-GMP compliance, pharmacovigilance interfaces and CMC documentation control so MAH responsibilities are managed across the product lifecycle.