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


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


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
?

Faster time to Market
Skip facility construction – start manufacturing immediately

Lower Capital risk
Limit investment in land, equipment and staffing

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

EASIER REGULATORY APPROVALS
Lean on our manufacturing and testing experience with validated processes

FLEXIBLE & SCALABLE MANUFACTURING
Adjust production volumes and logistics without reinvesting and choose from standard to customized solutions

ESTABLISHED EU SUPPLY CHAIN
Reduce lead times and navigate tariffs with our long time suppliers ensuring a secured supply chain

ACCESS TO TECHNICAL TALENT
Tap specialized expertise in development and production for high quality products

REDUCED OPERATIONAL RISK
Minimize exposure to geopolitical and economic uncertainties


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 client’s quality standards
- Production under validated SOPs ensuring consistency and compliance
- Custom labeling and packaging to align with the brand‘s 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 partner’s designated EU production site
CASE 1: PAN COMPLETE SERVICE
Your Subtitle Goes Here
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
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 client’s quality standards
- Production under validated SOPs ensuring consistency and compliance
- Custom labeling and packaging to align with the brand‘s 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
Your Subtitle Goes Here
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 partner’s designated EU production site