Our capabilities
Bringing pharmaceutical products to regulated markets requires more than just compliance—it demands strategic coordination, local insight, and technical precision. From regulatory readiness to commercial rollout, MEDITRA delivers the expertise to make global expansion seamless.
Regulatory Affairs
Navigate global compliance with strategic expertise
Regulatory Affairs
Navigate global compliance with strategic expertise
Regulatory Affairs
Navigate global compliance with strategic expertise
Market Access
Unlock pathways into complex, regulated markets.
Market Access
Unlock pathways into complex, regulated markets.
Market Access
Unlock pathways into complex, regulated markets.
Dossier Development
Build robust, submission-ready CTD dossiers.
Dossier Development
Build robust, submission-ready CTD dossiers.
Dossier Development
Build robust, submission-ready CTD dossiers.
GMP & Quality
Ensure GMP compliance and audit readiness.
GMP & Quality
Ensure GMP compliance and audit readiness.
GMP & Quality
Ensure GMP compliance and audit readiness.
Tech Transfer
Streamline validation and documentation workflows.
Tech Transfer
Streamline validation and documentation workflows.
Tech Transfer
Streamline validation and documentation workflows.
Pharmacovigilance
Maintain safety through global PV systems.
Pharmacovigilance
Maintain safety through global PV systems.
Pharmacovigilance
Maintain safety through global PV systems.
Customer Access
Connect with top-tier global pharma buyers.
Customer Access
Connect with top-tier global pharma buyers.
Customer Access
Connect with top-tier global pharma buyers.
*The capabilities listed above represent a selection of our core services. Additional expertise and tailored solutions are available upon request, depending on your specific regulatory, technical, or commercial needs.
MEDITRA turns complexity into opportunity—bridging science, strategy, and global ambition to move pharma forward.
MEDITRA turns complexity into opportunity—bridging science, strategy, and global ambition to move pharma forward.
MEDITRA turns complexity into opportunity—bridging science, strategy, and global ambition to move pharma forward.
The Meditra Advantage
The Meditra Advantage
The Meditra Advantage
01
Bridging Compliance and Commerce
Achieving regulatory approval is just the beginning—commercial success requires navigating complex market realities. Meditra understands this critical gap and provides full-spectrum support, from dossier adaptation to aligning product formats with local purchasing standards. We help Chinese manufacturers anticipate post-approval obligations such as serialization, pharmacovigilance, and reimbursement systems, ensuring each product is not only registered but positioned for sustainable success.
01
Bridging Compliance and Commerce
Achieving regulatory approval is just the beginning—commercial success requires navigating complex market realities. Meditra understands this critical gap and provides full-spectrum support, from dossier adaptation to aligning product formats with local purchasing standards. We help Chinese manufacturers anticipate post-approval obligations such as serialization, pharmacovigilance, and reimbursement systems, ensuring each product is not only registered but positioned for sustainable success.
01
Bridging Compliance and Commerce
Achieving regulatory approval is just the beginning—commercial success requires navigating complex market realities. Meditra understands this critical gap and provides full-spectrum support, from dossier adaptation to aligning product formats with local purchasing standards. We help Chinese manufacturers anticipate post-approval obligations such as serialization, pharmacovigilance, and reimbursement systems, ensuring each product is not only registered but positioned for sustainable success.
02
Trusted by Both Markets
Meditra is uniquely positioned with deep roots in China and strong ties across Europe, the Middle East, and Latin America. We are fluent in the expectations of regulators and buyers alike. With teams embedded locally in both ecosystems, we ensure real-time coordination, reduce delays caused by miscommunication, and create alignment between manufacturing execution and global market demands. This dual credibility translates into smoother approvals and stronger partnerships.
02
Trusted by Both Markets
Meditra is uniquely positioned with deep roots in China and strong ties across Europe, the Middle East, and Latin America. We are fluent in the expectations of regulators and buyers alike. With teams embedded locally in both ecosystems, we ensure real-time coordination, reduce delays caused by miscommunication, and create alignment between manufacturing execution and global market demands. This dual credibility translates into smoother approvals and stronger partnerships.
02
Trusted by Both Markets
Meditra is uniquely positioned with deep roots in China and strong ties across Europe, the Middle East, and Latin America. We are fluent in the expectations of regulators and buyers alike. With teams embedded locally in both ecosystems, we ensure real-time coordination, reduce delays caused by miscommunication, and create alignment between manufacturing execution and global market demands. This dual credibility translates into smoother approvals and stronger partnerships.
03
Execution Across the Lifecycle
Unlike advisory-only firms, Meditra delivers hands-on execution. We prepare your site for EU GMP inspections, coordinate with Qualified Persons for batch release, manage regulatory submissions and post-approval variations, and handle strategic commercial introductions. Our team leads critical phases—technical, regulatory, and commercial—ensuring every milestone is met with precision. For Chinese manufacturers aiming to scale internationally, we act as both partner and operator across the entire journey.
03
Execution Across the Lifecycle
Unlike advisory-only firms, Meditra delivers hands-on execution. We prepare your site for EU GMP inspections, coordinate with Qualified Persons for batch release, manage regulatory submissions and post-approval variations, and handle strategic commercial introductions. Our team leads critical phases—technical, regulatory, and commercial—ensuring every milestone is met with precision. For Chinese manufacturers aiming to scale internationally, we act as both partner and operator across the entire journey.
03
Execution Across the Lifecycle
Unlike advisory-only firms, Meditra delivers hands-on execution. We prepare your site for EU GMP inspections, coordinate with Qualified Persons for batch release, manage regulatory submissions and post-approval variations, and handle strategic commercial introductions. Our team leads critical phases—technical, regulatory, and commercial—ensuring every milestone is met with precision. For Chinese manufacturers aiming to scale internationally, we act as both partner and operator across the entire journey.
