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.

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.

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.

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.

Serialization
audit

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

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.

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Market Entry - serialization & traceability