Market Entry
- serialization & traceability

Unlock global markets with Nubbino Market Entry service, designed to streamline your pharmaceutical product’s compliance with serialization and traceability regulations.

Market entry- serialization and traceability

Nubinno Market Entry service is designed to facilitate the seamless introduction of your pharmaceutical products into global markets by ensuring full compliance with serialization and traceability (T&T) requirements.

We expertly manage registrations with regulatory bodies such as EMVO, MDLP, CFDA, and DAVA, while facilitating the effortless onboarding and integration of your partners into the supply chain. Achieve a smooth and compliant market entry with our tailored support.

Work with us

Comprehensive Market Entry Solutions: Registration, Compliance, and Partner Integration

Registrations:

  • EMVO (European Medicines Verification Organization): We manage the registration process with EMVO to ensure compliance with the Falsified Medicines Directive (FMD) in the EU, enabling secure and verified entry into the European market.
  • MDLP (Russia Drug Labeling System): Our team handles the complexities of registering with Russia's MDLP, ensuring your products meet the stringent requirements for traceability in the Russian Federation.
  • CFDA (China Food and Drug Administration): We facilitate the registration process with the CFDA, allowing for compliant market entry into China, where stringent serialization standards are enforced.
  • DAVA (Drug Authentication and Verification Application): We ensure your products are registered with DAVA, supporting compliance with track and trace systems in various markets.
  • Partner On-boardings: We provide end-to-end support in onboarding your partners into serialization and traceability systems, ensuring that all supply chain participants are fully integrated and compliant. This includes technical integration, compliance training, and ongoing support to ensure smooth operations.
Talk to an expert

Key benefits and services included:

  • Global Compliance: Navigate the complex regulatory landscapes of major markets with ease, ensuring your products meet all serialization and traceability requirements.
  • Effortless Partner Integration: Smooth onboarding and integration of your supply chain partners into required systems, minimizing disruptions and ensuring compliance across the board.
  • Expert Registration Management: Save time and resources with our expertise in handling registrations with key regulatory bodies like EMVO, MDLP, CFDA, and DAVA.
  • Services Included:
  • Regulatory Registrations: Full management of the registration process with EMVO (EU), MDLP (Russia), CFDA (China), and DAVA, ensuring your products are compliant with regional laws.
  • Partner Onboarding: Comprehensive support for integrating your partners into serialization and traceability systems, including technical integration and compliance training.
  • Ongoing Support: Continuous assistance to ensure your supply chain remains compliant with evolving regulations and system updates.
Get in touch

Our services

Serialization
Experts

Serialization Experts Service delivers agile and highly specialized support tailored to ensure business continuity in all serialization operations. Ensure seamless operation and compliance through our dedicated, multilingual support team and comprehensive technical solutions.

Learn more

Serialization
audit

Enhance your serialization operations with our serialization audit service, designed to ensure your processes align with industry standards and best practices.

Learn more

System implementations and integrations

Nubinno specializes in systems implementations and integrations serving as your trusted partner to optimize and ensure your systems work cohesively for a more efficient and compliant operation.

Learn more

Our references

"Serialization makes drugs safer for patients. Nubinno helped us to register and get ready for serializing of our products for the German market. They also support us with daily challenges of drugs verification from the technical perspective."
Piotr Błaszczyk
Piotr BłaszczykVice – President of the Management Board, Fosun Pharma Sp. z. o. o.
"We absolutely recommend the trainings organized by Nubinno. They delivered the training on how to work with L3 and L4 systems, which was organized in a very professional and clear way and the agenda, as well as the materials were fully customized for us."
Marcin Fajst
Marcin FajstJunior Quality Assurance Specialist/Serialization Coordinator, Celon Pharma S.A.
"Nubinno allows us to promptly solve technical issues on serialization of medicines. It is especially pleasant that technical support is provided in Russian for local colleagues. Thanks to this service, working with serialization has become simple and efficient."
Aliona Zlobina
Aliona ZlobinaCommercial Excellence & SFE manager, EVER Neuro Pharma LLC
"We were having certain challenges with our Russia Serialization operation in the warehouse. Nubinno team came in the short notice and managed to resolve our issues in a timely manner and very effectively."
Alena Andrianova
Alena AndrianovaIT system analytic, Torrent Pharma
“Nubinno provides professional support of our serialization processes and compliance procedures. They helped us to optimize our operations and to get ready for NCA audits and inspections. Nubinno team always goes above and beyond.”
Grzegorz Kaniowski
Grzegorz KaniowskiHead of Serialization, Bioton S.A.
“Nubinno was our partner in preparation of our product serialization. Ever since they are supporting us in daily services of our product serialization environment in a reliable and trustworthy manner.”
Piotr Zaleski
Piotr ZaleskiPharmaceutical Products Office, Łukasiewicz - IChP
“The service provided by Nubinno is over and above what is expected and can be described as exceptional. As a CMO, Siegfried - we thrive and are committed to our core values being Excellence, Passion, Integrity, Quality and Sustainability which can be found within the Nubinno team. This creates the basis for common values, actions and culture providing a firm foundation to ensure success with all customers.”
Mark Dalli
Mark DalliGlobal Coordinator Track & Trace, Siegfried Holding AG
"Nubinno team has helped us at the critical time when we needed to manage our external partner network quickly. Now we have been working with their team for 3 years on continuous support and evolution of our serialization compliance."
Ingrid Lerno
Ingrid LernoQA Manager / Responsible Person GDP

Your partner for global pharma serialization and compliance

From implementation to ongoing support, we provide end-to-end pharma serialization, track and trace, and compliance services (EU FMD, DSCSA). We design, implement, and manage serialization systems for global supply chains, ensuring seamless and compliant operations.

contact us
Scroll to Top
ndc change