Your Trusted EU Partnerfor Device Assembly &Secondary Packaging &Market Entry

BBLT Tech, a GMP-compliant CMO delivering reliable, scalable, and fully compliant pen device assembly, secondary packaging, serialization solutions - supporting pharmaceutical products from early-stage supply through to commercialization.

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GMP LicensedEudraGMDP RegisteredcGMP CompliantCleanrooms

About BBLT Tech

UAB BBLT Tech is a contract manufacturing organization (CMO) located in the European Union, operating from a purpose-built facility in Kaunas, Lithuania.

The company specializes in pharmaceutical secondary packaging, pre-filled injectable pen assembly, serialization, and physical importation of medicinal products — serving clients across EU and international markets.

The facility spans 1,514 m² and was fully reconstructed in 2024. It includes ISO 8 cleanrooms, cold and ambient storage areas, serialization stations, and integrated warehouse management via Microsoft Dynamics 365.

Facility Highlights

Manufacturing Authorization (MIA)

Registered at EudraGMDP. Covers secondary packaging (1.5.2) and importation of intermediates (2.3.2). Site of Physical Importation.

Full cGMP Compliance

ISO 8 cleanrooms, cold storage (+2–8°C, 282 m²), ambient storage (+15–25°C, 183 m²), with continuous EMS across all areas.

ERP-Integrated Operations

Powered by Microsoft Dynamics 365 ERP and WMS, our operations combine production planning, inventory management, quality oversight, and logistics into a unified digital workflow.

0m²Total FacilityReconstructed 2024

ISO 8CleanroomsAir quality standard

MIALicensedEU manufacturing license

What we do

Secondary Stage Manufacturing

BBLT Tech handles the secondary stage of pharmaceutical manufacturing — taking intermediate products and preparing them for the EU market.

Operations cover packaging, labelling, serialization, tamper-evidence application, and storage under fully controlled conditions. All processes are performed within a licensed, cGMP-compliant facility with complete documentation, environmental monitoring, and ERP-integrated traceability at every stage.

As an EU-based, MIA-licensed organization, BBLT Tech is positioned to support pharmaceutical companies entering or operating within the European market.

Your EU Gateway

Lithuania

YOUR EU GATEWAY

Physical importation of intermediate medicinal products which undergo further processing.

World map showing Lithuania as an EU gateway with physical importation connections to North America, South America, Asia, and Australia

Licensed EU Site for Physical Import of Medicinal Products

BBLT Tech operates a licensed EU site for the physical importation of intermediate medicinal products which undergo further processing, under a Manufacturing Authorisation (MIA) license category 2.3.2, issued by the Lithuanian Medicines Control Authority.

Our authorization covers the receipt and controlled handling of imported intermediate medicinal products, ensuring compliance with EU GMP requirements and applicable regulatory standards prior to subsequent manufacturing or packaging activities.

All imported materials are managed under strict controls to ensure product integrity, full traceability, and secure chain of custody from EU entry through to further processing stages.

This capability provides pharmaceutical partners with a compliant and reliable EU import gateway for intermediate medicinal products intended for downstream processing within regulated supply chains.

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Services

Contract Manufacturing Services

BBLT Tech offers the following contract manufacturing and packaging services:

Pre-Filled Pen Assembly

BBLT Tech provides GMP-compliant pre-filled pen device assembly within a validated EU manufacturing environment, ensuring reliability, regulatory alignment, and seamless integration into global pharmaceutical supply chains.

Our operations are built for high-volume, multi-market supply, supported by robust quality systems, serialization integration, and strict EU regulatory compliance.

This enables fast, compliant, and cost-effective entry into EU markets, while supporting long-term product lifecycle continuity from clinical supply to global commercialization.

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Secondary Packaging

While pre-filled pen assembly represents a core area of expertise, BBLT Tech offers a comprehensive portfolio of secondary packaging services applicable to a wide range of pharmaceutical products and formats including a flexible range of carton solutions, optimized for diverse injection systems, patient usability, and evolving regulatory requirements. Our capabilities include:

Development of packaging design
Cartoning (manual and automated)
Serialization and aggregation in line with EU FMD requirements
Repackaging and kitting
Artwork and regulatory compliance checks

Sourcing and supply control of all printed materials
Labeling and relabeling (including multi-language compliance)
Tamper-evident sealing and security features
Clinical trial packaging support
Returns handling and rework services

Our infrastructure and quality systems are designed to accommodate various dosage forms and product types, mostly injectables with cold temperature requirements but other forms are also available under request.

Digital Inspection System for Printed Materials

Our integrated software and hardware solution for digital inspection of printed pharmaceutical materials provides automated, high-precision quality control for packaging components. Designed for regulated environments, it enables reliable verification of artwork, barcode grading, and Braille inspection using high-resolution scanning and advanced analysis software.

Fully compliant with GAMP 5 and FDA 21 CFR Part 11, the system ensures data integrity, traceability, and audit readiness while supporting robust quality assurance processes.

By replacing manual inspection with automated digital validation, the solution delivers higher accuracy, faster processing, and consistent repeatability, while eliminating human error and reducing variability in quality control.

It also enables significant cost savings and operational efficiency gains through reduced manual workload, lower rejection rates, and faster batch release timelines.

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Additional Services

Serialization

Tamper-Evident Labelling

Labelling Services

Storage Capabilities

Supply of Packaging Materials

Application of unique serial numbers to individual product units using a semi-automated serialization station. Ensures full supply chain traceability in accordance with EU Falsified Medicines Directive (FMD) requirements.

Equipment-based application of tamper-evident labels to packaged pharmaceutical products, providing visible protection against unauthorized access or alteration.

On-demand labelling services including variable data: lot numbers, expiry dates, manufacturing dates, and product codes. Applied during or after the assembly and packaging process.

We offer controlled cold storage (+2—8°C) and ambient storage (+15—25°C) across dedicated GMP-compliant areas designed for pharmaceutical products. Both storage environments are supported by continuous environmental monitoring systems (EMS), interlocking access control, and full warehouse management system (WMS) integration via Microsoft Dynamics 365. This ensures secure handling, full traceability, and real-time inventory control in line with EU regulatory and quality requirements.

BBLT Tech can supply printed materials, tamper-evident labels, information leaflets, and secondary packaging components on behalf of clients.

Serialization

Tamper-Evident Labelling

Equipment-based application of tamper-evident labels to packaged pharmaceutical products, providing visible protection against unauthorized access or alteration.

Labelling Services

On-demand labelling services including variable data: lot numbers, expiry dates, manufacturing dates, and product codes. Applied during or after the assembly and packaging process.

Storage Capabilities

Supply of Packaging Materials

BBLT Tech can supply printed materials, tamper-evident labels, information leaflets, and secondary packaging components on behalf of clients.

Modern Pharmaceutical Facility

Our newly developed facility in Kaunas, Lithuania is designed for efficient and compliant pharmaceutical packaging operations. It includes cleanroom environments, temperature-controlled storage areas, and integrated production and logistics processes.

Our Facility

1,514 m²Total FacilityReconstructed 2024

Facility

The BBLT Tech facility is located in Kaunas, Lithuania, within the European Union. Fully reconstructed in spring 2024, the site was designed and built to pharmaceutical manufacturing standards from the ground up.

Facility Specifications

Area

Total site

Cleanrooms

Cold storage

Ambient storage

Air supply

Monitoring

Systems

Logistics

Details

1,514 m²

2 separate rooms with airlocks • ISO 8 (ISO 14644-1) • 15—25°C • ≤60% RH

Temperature-controlled cold storage area for medicinal products requiring refrigerated conditions

Dedicated ambient storage area for products requiring controlled room temperature conditions

Oil-free compressed air system

Full-site Environmental Monitoring System (EMS)

ERP + WMS integrated via Microsoft Dynamics 365

Multi-transport support for inbound and outbound shipments

Total site

1,514 m²

Cleanrooms

2 separate rooms with airlocks • ISO 8 (ISO 14644-1) • 15—25°C • ≤60% RH

Cold storage

Temperature-controlled cold storage area for medicinal products requiring refrigerated conditions

Ambient storage

Dedicated ambient storage area for products requiring controlled room temperature conditions

Air supply

Oil-free compressed air system

Monitoring

Full-site Environmental Monitoring System (EMS)

Systems

ERP + WMS integrated via Microsoft Dynamics 365

Logistics

Multi-transport support for inbound and outbound shipments

Quality & Compliance

All manufacturing, secondary packaging, serialization, and device assembly activities are performed in strict compliance with current Good Manufacturing Practice (cGMP) requirements.

Our quality system is designed to ensure product safety, data integrity, and full traceability across all operations, supported by validated processes, trained personnel, and continuous quality oversight.

This regulatory framework enables us to reliably support pharmaceutical partners with EU-compliant manufacturing and packaging solutions, ensuring readiness for inspections and audits across regulated markets.

cGMP Compliant
MIA Licensed
EudraGMDP Registered
ISO 8 Cleanrooms
GAMP5
FDA 21 CFR Part 11

Complete end-to-end quality control inspection of medical devices in a cleanroom — Complete End-to-End Quality Control

Precision device assembly of pharmaceutical syringes — Precision Device Assembly

Automated pharmaceutical packaging from components to market — From Components to Market

GMP Compliance and Manufacturing Authorisation

BBLT Tech operates under a Manufacturing Authorisation (MIA) granted by the Lithuanian Medicines Control Authority and is officially registered in the EudraGMDP database, ensuring full transparency and regulatory recognition within the European Union. All manufacturing, secondary packaging, serialization, and device assembly activities are performed in strict compliance with current Good Manufacturing Practice (cGMP) requirements.

Digitalized Quality Systems

Environmental conditions are continuously monitored through an integrated EMS. All operations are tracked via ERP and WMS, providing complete traceability from material receipt to final product dispatch. Digital incoming inspection compliant with GAMP5 and FDA 21 CFR Part 11.

Our People

Team

BBLT Tech is staffed by specialists across quality assurance, production, and regulatory functions. The team has direct experience in pharmaceutical manufacturing, medical device production, and EU regulatory compliance.

Qualified Persons

With more than 15 years of industry experience, our Qualified Person team provides expert oversight of GMP compliance, product quality, batch certification, and regulatory requirements across multiple dosage forms.

20+yrs combined

Quality Assurance & Control

The QA/QC team brings over 20 years of combined experience in quality and auditing functions across pharmaceutical, medical device, and electronics manufacturing environments. The team oversees product quality and compliance at every stage — from material receiving through to finished product dispatch.

7+yrs experience

Production

The production team has 7 years of hands-on experience in API manufacturing, medical device production, and secondary packaging services. The team manages the full process from raw materials to finished product, with in-depth knowledge of GMP requirements and technical problem-solving.

Contact

Let's discuss your packaging needs

Our team of experts is ready to assist you with GMP-compliant secondary packaging solutions. Reach out directly or book a consultation.

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