At PAN-Biotech, we understand the challenges of entering a new market.

 

That’s why we offer a full-service platform to help international companies start
their business, launch their product, or idea in Europe — to scale up and expand further.

 

From manufacturing and storage to distribution. We guide you at every step
of this path including regulatory support to ensure a smooth and successful market entry.

 

PAN-Biotech is your Gateway to Europe

Gateway to Europe

At PAN-Biotech, we understand the
challenges of entering a new market.

That’s Why we offer a full-service platform to help international companies start their business, launch their product, or idea in Europe — to scale up and expand further.

From manufacturing and storage to
distribution. We guide you at every step of this path including regulatory support to ensure a smooth and successful market entry.

As your European CMO and OEM partner, we provide agile and efficient production tailored to your needs.

MANUFACTURING

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Our two facilities in Aidenbach, Germany offer:

Fast implementation With flexible packaging (primary, secondary, tertiary)
• Lot sizes up to 1,000 L
• Sterile aseptic filling from 50 ml vials to 1,000 L Bags
• Production from RUO to GMP With full QC testings, QA documentation
• PAN Complete services: Manufacturing, Labeling, Quality Control, Quality Assurance, Packaging, Storage and Shipping

distribution

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We support your market presence across Europe with:

  • Broad distribution network covering all EU countries
  • Access into Academia, Biotech, Pharma, and Industry sectors
  • Active network for: R&D, Cell and Gene Therapy, Antibodies, mRNA and Vaccine Production

storage

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  • We offer secure, monitored storage from -20° C to room temperature
  • Separate storage is available for sensitive products (e.g., animal-free or antibiotic-free)
  • Use our site as your central EU logistics hub

shipping

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  • We ship globally with temperature-controlled logistics and full documentation
  • Our team is trained to meet GDP standards and can arrange certified forwarding partners to ensure regulatory compliance

testing & stability Studies

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  • We conduct extensive in-house quality testing and supplier traceability
  • Available tests include Sterility, Endotoxins, Mycoplasma, pH, Osmolality, RNase/DNase and more
  • Stability Studies up to 48 months are available in controlled conditions per an agreed plan

 

Making crucial steps is essential and we’re here to assist:

  • Growing brand awareness in Europe
  • Increasing EU sales Establishing a legal entity Support Regulatory affairs
GMP Ready Graphic
MAP IMAGE

EU-READY: SEAMLESS EXPANSION TO SCALE
YOUR BUSINESS IN EUROPE

 

Whether you’re a startup With ambitious goals or an established enterprise seeking new avenues, strategic expansion
is key to long-term success. For biotech and pharma companies, aiming to enter into the EU, partnering With a local
manufacturer/partner offers a smart, capital-efficient path to market access. By leveraging local expertise, infrastruc-
ture, and regulatory know-how, you can accelerate your EIJ entry and Stay focused on what matters most.

Why partner with PAN LOGO?

Faster time to Market

Skip facility construction – start manufacturing immediately
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Lower Capital risk

Limit investment in land, equipment and staffing
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LOCAL REGULATORY EXPERTISE

ISO 9001 and 13485 certified assure full compliance with GMP Annex 1-EU regulation /guidance
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EASIER REGULATORY APPROVALS

Lean on our manufacturing and testing experience with validated processes
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FLEXIBLE & SCALABLE MANUFACTURING

Adjust production volumes and logistics without reinvesting and choose from standard to customized solutions
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ESTABLISHED EU SUPPLY CHAIN

Reduce lead times and navigate tariffs with our long time suppliers ensuring a secured supply chain
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ACCESS TO TECHNICAL TALENT

Tap specialized expertise in development and production for high quality products
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REDUCED OPERATIONAL RISK

Minimize exposure to geopolitical and economic uncertainties
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PROVEN CONCEPTS

CASE 1: PAN COMPLETE SERVICE

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Due to the discontinuation of an existing supplier our partner
required a new manufacturer for their product.

As a FDA registration of the product and full customization
was
required they were facing a difficult situation to secure
their supply within a short time frame.

 

  • Successful FDA product registration
  • Setting up secure supply chain for complete customized packaging material
  • Raw material sourcing
  • Production according validated processes
  • Full QA / QC documentation
  • Labeling / Packing
  • Storage and On-demand shipping

CASE 2: OEM (ORIGINAL EQUIPMENT MANUFACTURING)

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A U.S.-based supplier of cell culture media was looking for an efficient, cost-effective solution to supply its products to customers across Europe.

Shipping from the U.S. was time-consuming and expensive, and the company needed a reliable partner to localize its operations in Europe without compromising on quality or control.

PAN-Biotech was selected as the OEM partner, delivering a fully integrated solution including manufacturing, storage, and global distribution, with a strong operational presence across Europe.

Key elements of the partnership are as follows:

  • Complete tech transfer of product specifications, packaging instructions, and shipping protocols
  • QC release following the clients quality standards
  • Production under validated SOPs ensuring consistency and compliance
  • Custom labeling and packaging to align with the brands global identity
  • Secure storage in a dedicated warehouse
  • On-demand drop-shipping to end users worldwide

CASE 3: CUSTOMIZED CMO / CDMO Service for Bottles and Bags - GMP Quality

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A global operating company based in Japan was looking for an European Contract Manufacturing Organization (CMO/CDMO) that could produce and supply custom-formulated products under GMP (EU Annex 1) standards. Their primary goal: to launch a private-label product line for distribution to customers across Europe while ensuring full regulatory compliance and seamless integration into existing GMP production environments.

Since than PAN-Biotech is providing a tailored CMO/CDMO service model built on flexibility, compliance, and trust.

Key elements included:

  • GMP-compliant production process development for both new and existing products
  • Customized packaging formats in single-use bags or bottles, designed to fit seamlessly into the partner’s GMP workflows
  • Full QC testing and QA documentation to meet European pharmaceutical standards
  • GDP-compliant logistics with transportation to the partners designated EU production site

CASE 1: PAN COMPLETE SERVICE

Your Subtitle Goes Here
3

Due to the discontinuation of an existing supplier our partner
required a new manufacturer for their product.

As a FDA registration of the product and full customization
was
required they were facing a difficult situation to secure
their supply within a short time frame.

  • Successful FDA product registration
  • Setting up secure supply chain for complete customized packaging material
  • Raw material sourcing
  • Production according validated processes
  • Full QA / QC documentation
  • Labeling / Packing
  • Storage and On-demand shipping

CASE 2: OEM (ORIGINAL EQUIPMENT MANUFACTURING)

Your Subtitle Goes Here
3

A U.S.-based supplier of cell culture media was looking for an efficient, cost-effective solution to supply its products to customers across Europe.

Shipping from the U.S. was time-consuming and expensive, and the company needed a reliable partner to localize its operations in Europe without compromising on quality or control.

PAN-Biotech was selected as the OEM partner, delivering a fully integrated solution including manufacturing, storage, and global distribution, with a strong operational presence across Europe.

Key elements of the partnership are as follows:

  • Complete tech transfer of product specifications, packaging instructions, and shipping protocols
  • QC release following the clients quality standards
  • Production under validated SOPs ensuring consistency and compliance
  • Custom labeling and packaging to align with the brands global identity
  • Secure storage in a dedicated warehouse
  • On-demand drop-shipping to end users worldwide

CASE 3: CUSTOMIZED CMO / CDMO Service for Bottles and Bags - GMP Quality

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A global operating company based in Japan was looking for an European Contract Manufacturing Organization (CMO/CDMO) that could produce and supply custom-formulated products under GMP (EU Annex 1) standards. Their primary goal: to launch a private-label product line for distribution to customers across Europe while ensuring full regulatory compliance and seamless integration into existing GMP production environments.

Since than PAN-Biotech is providing a tailored CMO/CDMO service model built on flexibility, compliance, and trust.

Key elements included:

  • GMP-compliant production process development for both new and existing products
  • Customized packaging formats in single-use bags or bottles, designed to fit seamlessly into the partner’s GMP workflows
  • Full QC testing and QA documentation to meet European pharmaceutical standards
  • GDP-compliant logistics with transportation to the partners designated EU production site